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Management of symptomatic vaginal discharge in pregnancy

Antenatal care

Evidence review T

NICE Guideline, No. 201

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4227-5

Management of symptomatic vaginal discharge in pregnancy

Review question

What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

Introduction

During normal pregnancy, most women will experience more vaginal discharge. If it is associated with symptoms such as itching, pain or an offensive smell it may be caused by an infection. Treating the infection may improve the woman’s symptoms and her pregnancy outcomes. The aim of this review is to investigate what interventions are effective in the management of symptomatic vaginal discharge in pregnancy.

Summary of the protocol

Please see Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

Table 1. Summary of the protocol (PICO table).

Table 1

Summary of the protocol (PICO table).

For further details see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual 2014. Methods specific to this review question are described in the review protocol in appendix A.

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

Clinical evidence

Included studies
Bacterial vaginosis

Two randomised controlled trials (RCTs) were included for the treatment of symptomatic vaginal discharge due to bacterial vaginosis in pregnant women (Duff 1991, Moniri 2009).

The included studies are summarised in Table 2.

One RCT compared 14-day course of oral antibiotic (amoxicillin) to placebo in pregnant women with symptomatic vaginal discharge due to bacterial vaginosis (Duff 1991), whilst 1 RCT compared a 7-day course of oral antibiotic (metronidazole) to no treatment (Moniri 2009).

One RCT was conducted in the USA (Duff 1991) and 1 RCT was conducted in Iran (Moniri 2009).

Vaginal trichomoniasis

There was no evidence identified on interventions to treat symptomatic vaginal discharge due to vaginal trichomoniasis.

Vaginal candidiasis

Two RCTs and 1 non-randomised controlled trial were included for the treatment of symptomatic vaginal discharge due to vaginal candidiasis in pregnant women (Abdelmonem 2012, Rubin 1980, Ruiz-Velasco 1978).

The included studies are summarised in Table 3.

One RCT compared a 6-day course of antifungal treatment (clotrimazole vaginal tablets and cream) to placebo (Ruiz-Velasco 1978). One RCT compared a 7-day course of antifungal treatment (econazole vaginal cream) to a 14-day course of treatment in black women only (Rubin 1980). One non-RCT compared a probiotic mixture (bee-honey and yogurt mixture applied vaginally) to antifungal treatment (tioconazole vaginal tablet) (Abdelmonem 2012).

One RCT was conducted in Mexico (Ruiz-Velasco 1978), 1 RCT was conducted in South Africa (Rubin 1980), and the non-RCT was conducted in Egypt (Abdelmonem 2012).

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review and reasons for their exclusions are provided in appendix K.

Summary of clinical studies included in the evidence review

A summary of the studies that were included in this review is presented in Table 2 and Table 3.

Table 2. Characteristics of included studies for treatment of symptomatic vaginal discharge due to bacterial vaginosis.

Table 2

Characteristics of included studies for treatment of symptomatic vaginal discharge due to bacterial vaginosis.

Table 3. Characteristics of included studies for treatment of symptomatic vaginal discharge due to vaginal candidiasis.

Table 3

Characteristics of included studies for treatment of symptomatic vaginal discharge due to vaginal candidiasis.

See the full evidence tables in appendix D and the forest plots in appendix E.

Quality assessment of clinical outcomes included in the evidence review

See the clinical evidence profiles in appendix F.

Economic evidence

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

A single economic search was undertaken for all topics included in the scope of this guideline. See supplementary material 2 for details.

Excluded studies

Economic studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.

Summary of studies included in the economic evidence review

No economic studies were identified which were applicable to this review question.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Clinical evidence statements

Bacterial vaginosis
Comparison 1. Oral antibiotic versus placebo
Critical outcomes
Preterm rupture of membrane

No evidence was identified to inform this outcome.

Preterm birth

No evidence was identified to inform this outcome.

Important outcomes
Rate of cure/Symptomatic relief
  • Moderate quality evidence from 1 RCT (N=81) showed that there is a clinically important difference favouring oral antibiotic (amoxicillin) over placebo on rate of microbiologic cure 2 weeks after treatment in pregnant women with symptomatic vaginal discharge due to bacterial vaginosis: RR 2.15 (95% CI 1.04 to 4.46).
Women’s experience and satisfaction of care

No evidence was identified to inform this outcome.

Fetal death from 16 weeks of gestational age

No evidence was identified to inform this outcome.

Infant death up to 1 year chronological age

No evidence was identified to inform this outcome.

Comparison 2. Oral antibiotic versus no treatment
Critical outcomes
Preterm rupture of membrane

No evidence was identified to inform this outcome.

Preterm birth
  • Low quality evidence from 1 RCT (N=120) showed that there is no clinically important difference between oral antibiotic (metronidazole) and no treatment on preterm birth in pregnant women with symptomatic vaginal discharge due to bacterial vaginosis after 7 days treatment: RR 1.00 (95%CI 0.15 to 6.87).
Important outcomes
Rate of cure/Symptomatic relief

No evidence was identified to inform this outcome.

Women’s experience and satisfaction of care

No evidence was identified to inform this outcome.

Fetal death from 16 weeks of gestational age

No evidence was identified to inform this outcome.

Infant death up to 1 year chronological age

No evidence was identified to inform this outcome.

Vaginal candidiasis
Comparison 3. Antifungal treatment versus placebo
Critical outcomes
Preterm rupture of membrane

No evidence was identified to inform this outcome.

Preterm birth

No evidence was identified to inform this outcome.

Important outcomes
Rate of cure/Symptomatic relief
  • Low quality evidence from 1 RCT (N=100) showed a clinically important difference favouring antifungal treatment (clotrimazole vaginal tablet and cream) over placebo on rate of mycological cure after 6 days treatment in pregnant women with symptomatic vaginal discharge due to vaginal candidiasis: RR 1.52 (95% CI 1.17 to 1.96).
Women’s experience and satisfaction of care

No evidence was identified to inform this outcome.

Fetal death from 16 weeks of gestational age

No evidence was identified to inform this outcome.

Infant death up to 1 year chronological age

No evidence was identified to inform this outcome.

Comparison 4. Antifungal treatment versus probiotic
Critical outcomes
Preterm rupture of membrane

No evidence was identified to inform this outcome.

Preterm birth

No evidence was identified to inform this outcome.

Important outcomes
Rate of cure/Symptomatic relief
Clinical cure rate
  • Very low quality evidence from 1 non-randomised controlled trial (N=129) showed no clinically important difference between antifungal treatment (local tioconazole tablet) and probiotics (bee-honey and yoghurt mixture) on the clinical cure rate after 7 days of treatment in pregnant women with symptomatic vaginal candidiasis: RR 0.82 (95% CI 0.68 to 1.00).
Mycological cure rate
  • Very low quality evidence from 1 non-randomised controlled trial (N=129) showed no clinically important difference between antifungal treatment (local tioconazole tablet) and probiotics (bee-honey and yoghurt mixture) on the mycological cure rate after 7 days of treatment in pregnant women with symptomatic vaginal candidiasis: RR 1.19 (95% CI 1.03 to 1.38).
Women’s experience and satisfaction of care

No evidence was identified to inform this outcome.

Fetal death from 16 weeks of gestational age

No evidence was identified to inform this outcome.

Infant death up to 1 year chronological age

No evidence was identified to inform this outcome.

Comparison 5. Antifungal treatment: 14 days versus 7 days
Critical outcomes
Preterm rupture of membrane

No evidence was identified to inform this outcome.

Preterm birth

No evidence was identified to inform this outcome.

Important outcomes
Rate of cure/Symptomatic relief
  • Very low quality evidence from 1 RCT (N=57) showed that there is a clinically important difference favouring a 7-day course of antifungal treatment (econazole vaginal cream) over a 14-day course of treatment on the rate of cure in pregnant women with symptomatic vaginal candidiasis: RR 0.64 (95% CI 0.43 to 0.94).
Women’s experience and satisfaction of care

No evidence was identified to inform this outcome.

Fetal death from 16 weeks of gestational age

No evidence was identified to inform this outcome.

Infant death up to 1 year chronological age

No evidence was identified to inform this outcome.

Economic evidence statements

No economic studies were identified which were applicable to this review question.

The committee’s discussion of the evidence

Interpreting the evidence
The outcomes that matter most

Preterm rupture of membrane and preterm birth were considered to be critical outcomes because vaginal infection during pregnancy may be associated with preterm birth. The outcomes of rate of cure and symptomatic relief were considered as important outcomes because they indicate whether a treatment is effective. Women’s experience and satisfaction of care was also an important outcome because women’s views and experience are central to how they are cared for. Perinatal and infant mortality were considered as important rather than critical outcomes because the committee considered it to be indirect consequence of vaginal infection rather than of the interventions themselves.

The quality of the evidence

The quality of the evidence on the use of oral antibiotics to treat symptomatic vaginal discharge due to bacterial vaginosis ranged from moderate to low quality. For the comparison of oral antibiotics versus placebo, the outcome of rate of mycological cure at 2 weeks follow up was of moderate quality due to imprecision of the effect estimate. No evidence was identified for preterm rupture of membrane, preterm birth, women’s experience and satisfaction of care, fetal death or infant death. For the comparison of oral antibiotics versus no treatment, the quality of evidence on the outcome of preterm birth was low due to imprecision of the effect estimate. No evidence was identified for preterm rupture of membrane, rate of cure/symptom relief, women’s experience and satisfaction of care, fetal death or infant death. No evidence was identified for the use of vaginal antibiotics nor on the use of oral clindamycin in pregnant women with symptomatic vaginal discharge due to bacterial vaginosis.

The quality of the evidence on the use of antifungal treatment (clotrimazole tablet/cream) to treat symptomatic vaginal discharge due to vaginal candidiasis ranged from low to very low. For the comparison of antifungal treatment versus placebo, the quality of evidence for the outcome of mycological cure after 6 days of treatment was moderate quality due to serious overall risk of bias and imprecision in the effect estimate. No evidence was identified for preterm rupture of membrane, preterm birth, women’s experience and satisfaction of care, fetal death or infant death. For the comparison of antifungal treatment (tioconazole tablet) versus probiotics, the outcome of clinical and mycological cure were both of very low quality due to serious risk of bias, indirectness (it was unclear whether the probiotic mixture used ‘live’ lactobacillus) and imprecision of the effect estimate. No evidence was identified for preterm rupture of membrane, preterm birth, women’s experience and satisfaction of care, fetal death or infant death. For the comparison of a 14-day course versus a 7-day course of antifungal treatment (econozale cream), the outcome of mycological cure rate was of very low quality due to serious overall risk of bias, indirectness (the trial was conducted in 1990, in a sample of Black African women only) and imprecision in the effect estimate. No evidence was identified for preterm rupture of membrane, preterm birth, women’s experience and satisfaction of care, fetal death or infant death.

No relevant evidence was identified on treatment of symptomatic vaginal discharge due to vaginal trichomoniasis.

Benefits and harms

The committee agreed that there is a need to balance the potential benefit of treating infections causing symptomatic vaginal discharge to the potential harm the treatment could cause. The committee also agreed that it is important to consider the harm of overusing antimicrobial therapies which may lead to antimicrobial resistance. Overall, the committee agreed that the evidence for the treatment of symptomatic vaginal discharge due to bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis is very limited. The limited evidence suggested that antibiotics and antifungal treatment are likely effective in treating the symptoms/infection, however, it is not known whether the use of antibiotics, antifungals, or probiotics to treat symptomatic vaginal discharge caused by an infection pose a risk to the pregnant women or the baby.

Information about vaginal discharge

Some pregnant women who have vaginal discharge may find it distressing or uncomfortable. The committee therefore agreed, using their knowledge and experience, to recommend that pregnant women be reassured that vaginal discharge is a normal physiological change during pregnancy, however, they should also be made aware that when there are other symptoms associated with the vaginal discharge, this may indicate an infection. Depending on the situation, this may warrant investigations and treatment.

Appropriate investigations

Symptomatic vaginal discharge can be caused by a variety of infections, including bacterial vaginosis, trichomoniasis, candidiasis or sexually transmitted infections such as chlamydia. The committee agreed that sometimes the clinical picture is clear and there is no need to conduct investigations to confirm the cause of the symptoms. However, the committee agreed, using their knowledge and experience, that it was important that a recommendation is made that when the cause of symptomatic discharge is not clinically obvious, appropriate investigations should be considered. In many cases this means a vaginal swab test. When there is a concern that the symptomatic vaginal discharge could be due to sexually transmitted infection, appropriate investigations should be considered so that it can be appropriately managed and the risk to the woman and the baby posed by untreated infections be mitigated.

Antibiotic treatment for bacterial vaginosis

Overall, the committee recognised that the evidence on the benefits and harms of antibiotics for treatment of symptomatic vaginal discharge due to bacterial vaginosis was very limited, with only two RCTs identified and limited outcomes reported. The committee noted that it is common practice to prescribe vaginal or oral antibiotics – in particular, vaginal clindamycin or oral metronidazole - and therefore agreed, using their knowledge and experience, that a general recommendation for the use of antibiotics should be made. The committee also recognised that there is a substantial body of evidence that antibiotics are effective in the asymptomatic population – that is, women who are known to have bacterial vaginosis but who do not have any symptoms – but that they could not assume that they were clinically effective in the symptomatic population.

For the comparison of oral antibiotic versus placebo, one RCT conducted in pregnant women showed that the probability of mycological cure in participants who received oral amoxicillin for 14 days was 2.15 times as high as the probability of cure in those who received placebo (41% vs 19% cured, respectively) at two-weeks follow up. However, this study did not report any other outcomes of interest to provide a more comprehensive view of the benefits and harms. However, the committee noted that the study was small, conducted over 30 years ago, and that the use of oral amoxicillin to treat vaginal discharge due to bacterial vaginosis is not common in current practice in the UK. The committee were also aware that there is some suggestion that amoxicillin use in the first trimester may be associated with an increased risk of oral clefts in babies.

For the comparison of oral antibiotic versus no treatment, one RCT found that there was no difference in preterm birth between pregnant women who received a 7-day course of oral metronidazole and those who received no treatment, with less than 4% of the sample (2% in each arm) giving birth before 37+0 weeks. No other outcomes were reported by the study so the overall picture of benefits and harms is uncertain.

Antifungal treatment for vaginal candidiasis

The evidence on the use of antifungal and probiotics to treat symptomatic vaginal discharge due to vaginal candidiasis was limited, with all 3 studies only reporting the outcome of rate of cure. The committee noted that all the included studies used vaginal imidazole-based antifungal treatments and that they were effective on the outcome of mycological cure with over 80% of women in the antifungal groups having a negative culture after treatment.

One RCT found that pregnant women who received vaginal clotrimazole tablets and cream were more likely to be cured after 6 days treatment, as assessed by mycological tests, compared to placebo tablet and cream. This study did not report any other benefits and harms of interest.

One non-RCT found no important difference in clinical or mycological cure rate between women who received vaginal tiaconozale tablets and those who applied a bee honey and yoghurt mixture vaginally. This study did not report any other benefits and harms of interest. The committee noted some women may prefer treatment with probiotics rather than antifungals. However, the non-randomised controlled study was at serious overall risk of bias and did not specify the strain of lactobacillus used in the study. Given this, and since there are over 180 species of lactobacillus, the committee agreed that no recommendation about the use of probiotics could be made.

Finally, one RCT compared a 14-day course of antifungal treatment (vaginal econazole cream) to a 7-day course followed by no treatment for 7 days and found that women in the 14-day group were less likely to be mycologically cured than those in the 7-day group at the end of treatment. No other benefits and harms of interest were reported in this study. The committee noted that it is common practice to prescribe a 7-day course of vaginal antifungal treatment and that there was not sufficient evidence to further specify duration of antifungal treatment.

Based on the evidence that antifungal treatments were effective, the committee agreed to recommend offering imidazole to women with symptomatic vaginal discharge due to vaginal candidiasis. Since the various vaginal imidazoles examined by the studies can be assumed to have a similar mechanism of action, the committee agreed to recommend a vaginal imidazole and not a specific type of imidazole, although they recognised that not all types of imidazole are used for treating vaginal candidiasis.

Cost effectiveness and resource use

No economic studies were identified which were applicable to this review question.

These recommendations reinforce current practice and there is unlikely to be any impact on resource use or costs.

References

  • Abdelmonem 2012

    Abdelmonem, A. M., Rasheed, S. M., Mohamed, A. S., Bee-honey and yogurt: A novel mixture for treating patients with vulvovaginal candidiasis during pregnancy, Archives of gynecology and obstetrics, 286, 109–114, 2012. [PubMed: 22314434]
  • Duff 1991

    Duff, P., Lee, M.L., Hillier, S.L., et al. Amoxicillin treatment of bacterial vaginosis during pregnancy. Obstetrics & Gynaecology, 77: 431–4351991. [PubMed: 1992412]
  • Moniri 2009

    Moniri, R., Behrashi, M., Effects of metronidazole therapy on preterm labor in women with bacterial vaginosis, Acta Medica Iranica, 47, 181–184, 2009.
  • Rubin 1980

    Rubin, A., Russell, J. M., Mauff, A., Efficacy of econazole in the treatment of candidiasis and other vaginal discharges, S Afr Med JSouth African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 57, 407–8, 1980. [PubMed: 7403993]
  • Ruiz-Velasco 1978

    Ruiz-VelascoV, Rosas-ArceoJ. Prophylactic clotrimazole treatment to prevent mycoses contamination of the newborn. International Journal of Gynaecology and Obstetrics;16:70–1, 1978. [PubMed: 32096]

Appendices

Appendix E. Forest plots

Forest plots for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis or vaginal candidiasis during pregnancy?

There are no forest plots for this review as no meta-analysis was conducted.

Appendix G. Economic evidence study selection

Economic evidence for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

A single economic search was undertaken for all topics included in the scope of this guideline. No economic studies were identified which were applicable to this review question. See supplementary material 2 for details.

Appendix H. Economic evidence tables

Economic evidence tables for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

No evidence was identified which was applicable to this review question.

Appendix I. Health economic evidence profiles

Health economic evidence for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

No evidence was identified which was applicable to this review question.

Appendix J. Health economic analysis

Health economic analysis for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

Clinical studies

Table 11Excluded studies

StudyReason for exclusion
Abbaspoor, Z., Comparison effect of vitamin C vaginal tablet with metronidazole vaginal gel treatment and relapse of bacterial vaginosis, Clinical Microbiology and Infection, 15 (S4), S181, 2009 Study design does not meet protocol eligibility criteria - conference abstract.
Agency for Healthcare, Research, Quality,, Screening and treatment for bacterial vaginosis in pregnancy: systematic review to update the 2001 U.S. Preventive Services Task Force recommendation, 21, 2008 [PubMed: 20722152] Study population not eligible - pregnant women asymptomatic for BV
Alsaad, A. M. S., Kaplan, Y. C., Koren, G., Exposure to fluconazole and risk of congenital malformations in the offspring: A systematic review and meta-analysis, Reproductive Toxicology, 52, 78–82, 2015 [PubMed: 25724389] Study outcomes do not meet protocol eligibility criteria - congenital malformations, heart defects, craniofacial defects, limb/musculoskeletal defects.
Andrews,W.W., Goldenberg,R.L., Hauth,J.C., Cliver,S.P., Copper,R., Conner,M., Interconceptional antibiotics to prevent spontaneous preterm birth: A randomized clinical trial, Obstetrical and Gynecological Survey, 61, 496–497, 2006 Study does not meet protocol eligibility criteria - unclear whether women symptomatic (cultures of various microorganisms other than those of interest); combination of antibiotics not relevant to protocol.
Anonymous,, Do not use metronidazole to prevent delivery, Pharmaceutical Journal, 276, 63, 2006 Study design does not meet protocol eligibility criteria - Opinion article.
Anonymous,, The management of women of reproductive age attending non-genitourinary medicine settings complaining of vaginal discharge, Journal of Family Planning and Reproductive Health Care, 32, 33–41, 2006 [PubMed: 16492336] Guidance - relevant references checked.
Bagnall, P., Rizzolo, D., Bacterial vaginosis: A practical review, JAAPA : official journal of the American Academy of Physician Assistants, 30, 15–21, 2017 [PubMed: 29135564] study design not eligible per protocol - narrative commentary
Bellad, M. B., Chalasani, P., Ganachari, M. S., Goudar, S. S., Sloan, N. L., Hoffman, M. K., Derman, R. J., Oral clindamycin to prevent preterm birth: A randomized placebo controlled trial in South India, Journal of SAFOG, 7, 191–196, 2015 Study population does not meet protocol eligibility criteria - unclear whether women had symptomatic vaginal discharge.
Bellad, M. B., Hoffman, M. K., Mallapur, A. A., Charantimath, U. S., Katageri, G. M., Ganachari, M. S., Kavi, A., Ramdurg, U. Y., Bannale, S. G., Revankar, A. P., Sloan, N. L., Kodkany, B. S., Goudar, S. S., Derman, R. J., Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial, BJOG: An International Journal of Obstetrics & Gynaecology, 22, 22, 2018 [PubMed: 29790266] Study population does not meet protocol eligibility criteria - unclear whether women had symptomatic vaginal discharge.
Brocklehurst, P., Gordon, A., Heatley, E., Milan, S. J., Antibiotics for treating bacterial vaginosis in pregnancy, Cochrane Database of Systematic Reviews, 1, CD000262, 2013 [PubMed: 23440777] Systematic review: no additional included studies (majority of studies are in asymptomatic population)
Carter, T. C., Druschel, C. M., Romitti, P. A., Bell, E. M., Werler, M. M., Mitchell, A. A., National Birth Defects Prevention, Study, Antifungal drugs and the risk of selected birth defects, American Journal of Obstetrics & GynecologyAm J Obstet Gynecol, 198, 191.e1–7, 2008 [PubMed: 18226621] Study design does not meet protocol eligibility criteria - Case control study.
Cruciani, F., Brigidi, P., Calanni, F., Lauro, V., Tacchi, R., Donders, G., Peters, K., Guaschino, S., Vitali, B., Efficacy of rifaximin vaginal tablets in treatment of bacterial vaginosis: A molecular characterization of the vaginal microbiota, Antimicrobial agents and chemotherapy, 56, 4062–4070, 2012 [PMC free article: PMC3421556] [PubMed: 22585228] Study population does not meet protocol eligibility criteria - non-pregnant women.
Danti, L., Gerosa, V., Rinaldo, D., Caria, M., Lupi, G., D’Oria, P., Lojacono, A., Sartori, E., Utility of a vaginal probiotic therapy in pregnancies complicated by bacterial vaginosis, Reproductive Sciences, 1), 127A, 2016 Study design does not meet protocol eligibility criteria - conference abstract.
Darwish,A., Elnshar,E.M., Hamadeh,S.M., Makarem,M.H., Treatment options for bacterial vaginosis in patients at high risk of preterm labor and premature rupture of membranes, Journal of Obstetrics and Gynaecology Research, 33, 781–787, 2007 [PubMed: 18001442] Study design does not meet protocol eligibility criteria - Prospective cohort study.
Daskalakis, G. J., Karambelas, A. K., Vaginal Probiotic Administration in the Management of Preterm Premature Rupture of Membranes, Fetal diagnosis and therapy, 42, 92–98, 2017 [PubMed: 27744438] Study population does not meet protocol eligibility criteria - unclear whether preterm premature rupture of membranes due to conditions of interest.
Daskalakis, G., Karambelas, A., Theodora, M., Antsaklis, P., Sindos, M., Asimakopoulos, G., Maritsa, V., Papantoniou, N., Antsaklis, A., Loutradis, D., Preterm premature rupture of membranes and probiotics, Journal of Perinatal Medicine, 45 (Supplement 2), 541, 2017 Study design does not meet protocol eligibility criteria - conference abstract.
Daskalakis, G., Karampelas, A., Gavrili, V., Papantoniou, N., Angelopoulos, P., Ntomali, A., Mesogitis, S., Probiotics for preterm premature rupture of membranes, Journal of maternal fetal & neonatal medicine, 27, 2014 Study design does not meet protocol eligibility criteria - conference abstract.
Del Palacio-Hernanz, A., Sanz-Sanz, F., Rodriquez-Noriega, A., Double-blind investigation of R-42470 (terconazole cream 0.4%) and clotrimazole (cream 1%) for the topical treatment of mycotic vaginitis, ChemioterapiaChemioterapia : international journal of the Mediterranean Society of Chemotherapy, 3, 192–5, 1984 [PubMed: 6529776] The full-text publication of this article was unavailable
Denison, H. J., Worswick, J., Bond, C. M., Grimshaw, J. M., Mayhew, A., Gnani Ramadoss, S., Robertson, C., Schaafsma, M. E., Watson, M. C., Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush), Cochrane Database of Systematic Reviews, 2020 [PMC free article: PMC8095055] [PubMed: 32845024] Does not include any pregnant women.
Di Pierro, F., Parolari, A., Brundu, B., Nigro, R., Positive clinical outcomes derived from using a proprietary mixture of selected strains during pregnancy, Acta Bio-Medica de l Ateneo ParmenseActa Biomed Ateneo Parmense, 87, 259–265, 2017 [PMC free article: PMC10521898] [PubMed: 28112691] Study population does not meet protocol eligibility criteria - proportion of women with vaginosis not clear.
Diaz-Cueto, L., Dominguez-Lopez, P., Tena-Alavez, G., Cuica-Flores, A., Rosales-Ortiz, S., Arechavaleta-Velasco, F., Effect of clindamycin treatment on vaginal inflammatory markers in pregnant women with bacterial vaginosis and a positive fetal fibronectin test, International journal of gynaecology and obstetrics, 107, 143–146, 2009 [PubMed: 19647824] Study outcomes do not meet protocol eligibility criteria - vaginal inflammatory markers.
Donders, G. G. G., Guaschino, S., Peters, K., Tacchi, R., Lauro, V., A multicenter, double-blind, randomized, placebo-controlled study of rifaximin for the treatment of bacterial vaginosis, International Journal of Gynecology and Obstetrics, 120, 131–136, 2013 [PubMed: 23273888] Study population does not meet protocol eligibility criteria - non-pregnant women.
Donders, G. G., Zodzika, J., Rezeberga, D., Treatment of bacterial vaginosis: What we have and what we miss, Expert Opinion on Pharmacotherapy, 15, 645–657, 2014 [PubMed: 24579850] Study design does not meet protocol eligibility criteria - Narrative review.
Donders, G., Bellen, G., Donders, F., Pinget, J., Vandevelde, I., Michiels, T., Byamughisa, J., Improvement of abnormal vaginal flora in Ugandan women by self-testing and short use of intravaginal antimicrobials, European Journal of Clinical Microbiology and Infectious Diseases, 36, 731–738, 2017 [PubMed: 27933401] Study population does not meet protocol eligibility criteria - non-pregnant women.
Edwards, J. E., Schwartz, M. M., Schmidt, C. S., Sobel, J. D., Nyirjesy, P., Schodel, F., Marchus, E., Lizakowski, M., Demontigny, E. A., Hoeg, J., et al.,, A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial, Clinical infectious diseases, 66, 1928–1936, 2018 [PMC free article: PMC5982716] [PubMed: 29697768] Study intervention does not meet protocol eligibility criteria - immunotherapeutic vaccine.
Facchinetti, F., Dante, G., Pedretti, L., Resasco, P., Annessi, E., Dodero, D., The role of oral probiotic for bacterial vaginosis in pregnant women. A pilot study, Minerva ginecologica, 65, 215–221, 2013 [PubMed: 23598785] Study does not meet protocol eligibility criteria - Non-English article.
Fredstorp, M., Jonasson, A. F., Barth, A., A new effective antibiotic-free bacterial vaginosis treatment at single-dose administration: A randomized multicenter open-label parallel-group two-part study with a novel sustained-release vaginal tablet containing oligomeric lactic acid, International Journal of Gynecology and Obstetrics, 5), E470, 2015 Study design does not meet protocol eligibility criteria - conference abstract.
French,J.I., McGregor,J.A., Draper,D., Parker,R., McFee,J., Gestational bleeding, bacterial vaginosis, and common reproductive tract infections: risk for preterm birth and benefit of treatment, Obstetrics and Gynecology, 93, 715–724, 1999 [PubMed: 10912974] No relevant data
Giuffrida, G., Mangiacasale, A., Bacterial vaginosis in pregnancy: treatment with Peroxen vs vaginal Clindamycin, Giornale italiano di ostetricia e ginecologia, 28, 539–543, 2006 Study does not meet protocol eligibility criteria - non-English language article.
Giunta, G., Giuffrida, L., Mangano, K., Fagone, P., Cianci, A., Influence of lactoferrin in preventing preterm delivery: a pilot study, Molecular medicine reports, 5, 162–166, 2012 [PubMed: 21922138] Study intervention does not meet protocol eligibility criteria - iron-binding glycoprotein (Lactoferrin).
Gómez, S., Agramunt, S., Checa, M. A., Carreras, R., Antibiotic treatment for prevention pretem birth in pregnant woman with bacterial vaginosis. A systematic review and a meta-analysis, Journal of Maternal-Fetal & Neonatal MedicineJ Matern Fetal Neonatal Med, 23, 611–612, 2010 Systematic review includes studies of asymptomatic population
Gomez, S., Agramunt, S., Checa, M. A., Carreras, R., Antibiotic treatment for prevention pretem birth in pregnant woman with bacterial vaginosis. A systematic review and a meta-analysis, Journal of Maternal-Fetal and Neonatal Medicine, 1), 611–612, 2010 Study design does not meet protocol eligibility criteria - conference abstract.
Gottschick, C., Deng, Z. L., Vital, M., Masur, C., Abels, C., Pieper, D. H., Rohde, M., Mendling, W., Wagner-Dobler, I., Treatment of biofilms in bacterial vaginosis by an amphoteric tenside pessary-clinical study and microbiota analysis, Microbiome, 5, 119, 2017 [PMC free article: PMC5598074] [PubMed: 28903767] Study does not meet protocol eligibility criteria - healthy women (unclear whether pregnant or not); treatment comparison not relevant (amphoteric tenside versus lactic acid pessaries) for bacterial vaginosis.
Gülmezoglu, A. M., Azhar, M., Interventions for trichomoniasis in pregnancy, Cochrane Database of Systematic Reviews, 2011 [PMC free article: PMC7044808] [PubMed: 21563127] Systematic review: included studies checked for consistency.
Gulmezoglu, AM. , Interventions for trichomoniasis in pregnancy. , Cochrane Database of Systematic Reviews, No: CD000220, 2002 [PubMed: 12137609] Systematic review - no additional relevant studies
Gupta,S., Tripathi,R., Singh,N., Bhalla,P., Ramji,S., Mala,Y.M., Pregnancy outcome in asymptomatic women with abnormal vaginal flora without any treatment and after treatment with vaginal clindamycin and clotrimazole: A randomised controlled trial, South African Journal of Obstetrics and Gynaecology, 19, 35–38, 2013 Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Haahr, T., Jensen, J. S., Thomsen, L., Duus, L., Rygaard, K., Humaidan, P., Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients, Human reproduction (oxford, england), 31, 795–803, 2016 [PubMed: 26911864] Study population does not meet eligibility criteria - infertile women undergoing IVF.
Haahr, T., Zacho, J., Brauner, M., Shathmigha, K., Skov Jensen, J., Humaidan, P., Reproductive outcome of patients undergoing in vitro fertilisation treatment and diagnosed with bacterial vaginosis or abnormal vaginal microbiota: a systematic PRISMA review and meta-analysis, BJOG: An International Journal of Obstetrics & Gynaecology, 22, 22, 2018 [PubMed: 29469992] Study population does not meet protocol eligibility criteria - infertile women undergoing IVF.
Haji Foghaha, M., Keshavarz, T., Parsanezhad, M. E., Rajaeifard, A. R., Prevention of premature rupture of membranes and preterm labor in Shiraz, Iran, Iranian Journal of Reproductive Medicine, 1), 124, 2010 Study design does not meet protocol eligibility criteria - conference abstract.
Hantoushzadeh,S., Golshahi,F., Javadian,P., Khazardoost,S., Aram,S., Hashemi,S., Mirarmandehi,B., Borna,S., Comparative efficacy of probiotic yoghurt and clindamycin in treatment of bacterial vaginosis in pregnant women: a randomized clinical trial, Journal of Maternal-Fetal and Neonatal Medicine, 25, 1021–1024, 2012 [PubMed: 21854132] Study comparison does not meet protocol eligibility criteria - probiotics not a relevant comparator for bacterial vaginosis.
He, A., Chin, J., Lomiguen, C. M., Benefits of Probiotic Yogurt Consumption on Maternal Health and Pregnancy Outcomes: A Systematic Review, CureusCureus, 12, e9408, 2020 [PMC free article: PMC7449615] [PubMed: 32864237] This review does not include interventions for treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis or vaginal candidiasis during pregnancy
Holt, S., Vaginal vitamin C tablets effective for bacterial vaginosis, Focus on alternative and complementary therapies, 17, 71–72, 2012 Study intervention does not meet protocol eligibility criteria - vitamin C.
Jarde, A., Lewis-Mikhael, A. M., Moayyedi, P., Stearns, J. C., Collins, S. M., Beyene, J., McDonald, S. D., Pregnancy outcomes in women taking probiotics or prebiotics: a systematic review and meta-analysis, BMC Pregnancy & ChildbirthBMC Pregnancy Childbirth, 18, 14, 2018 [PMC free article: PMC5759212] [PubMed: 29310610] Study populations do not meet protocol eligibility criteria - non-infected pregnant women.
Joesoef, M., Schmid, G., Bacterial vaginosis, Clinical EvidenceClin Evid, 1592–600, 2002 [PubMed: 12603956] Study has been updated and update is available published 2005, already captured
Karampelas, A., Daskalakis, G., Papantoniou, N., Gavrili, V., Mesogitis, S., Angelopoulos, P., Antsaklis, A., Probiotics for preterm premature rupture of membranes, Journal of Perinatal Medicine. Conference: 11th World Congress of Perinatal Medicine, 41, 2013 Study design does not meet protocol eligibility criteria - conference abstract.
Kenyon,S., Brocklehurst,P., Jones,D., Marlow,N., Salt,A., Taylor,D., MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes, BMC Pregnancy and Childbirth, 8, 14-, 2008 [PMC free article: PMC2386115] [PubMed: 18435833] Study population does not meet protocol eligibility criteria - PROM was not specifically due to the conditions of interest for this review.
Kenyon,S., Pike,K., Jones,D.R., Brocklehurst,P., Marlow,N., Salt,A., Taylor,D.J., Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial, Lancet, 372, 1310–1318, 2008 [PubMed: 18804274] Study population does not meet protocol eligibility criteria - unclear whether preterm rupture of the membranes due to conditions of interest.
Kirihara, N., Kamitomo, M., Tabira, T., Hashimoto, T., Taniguchi, H., Maeda, T., Effect of probiotics on perinatal outcome in patients at high risk of preterm birth, Journal of Obstetrics & Gynaecology ResearchJ Obstet Gynaecol Res, 44, 241–247, 2018 [PubMed: 28994162] Study does not meet protocol eligibility criteria - probiotics administered to women with bacterial vaginosis or constipation (proportion of women with bacterial vaginosis not reported); probiotics not relevant intervention for bacterial vaginosis.
Kiss, H., Petricevic, L., Husslein, P., Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery, BMJ, 329, 371, 2004 [PMC free article: PMC509340] [PubMed: 15294856] Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Kiss,H., Petricevic,L., Martina,S., Husslein,P., Reducing the rate of preterm birth through a simple antenatal screen-and-treat programme: a retrospective cohort study, European Journal of Obstetrics, Gynecology, and Reproductive Biology, 153, 38–42, 2010 [PubMed: 20675037] Study does not meet protocol eligibility criteria - pregnant women treated with standard regimens for bacterial vaginosis, candidiasis, and trichomoniasis, but outcome data not reported separately.
Koss, C. A., Baras, D. C., Lane, S. D., Aubry, R., Marcus, M., Markowitz, L. E., Koumans, E. H., Investigation of metronidazole use during pregnancy and adverse birth outcomes, Antimicrobial Agents and Chemotherapy, 56, 4800–4805, 2012 [PMC free article: PMC3421860] [PubMed: 22751543] Study does not meet protocol eligibility criteria - unclear whether symptomatic pregnant women; outcomes not reported separately for women with trichomoniasis and treated with metronidazole vs no treatment; chart review.
Koumans, E. H., Lane, S. D., Aubry, R., Demott, K., Webster, N., Levandowski, B. A., Berman, S., Markowitz, L. E., Evaluation of Syracuse Healthy Start’s program for abnormal flora management to reduce preterm birth among pregnant women, Maternal and Child Health Journal, 15, 1020–1028, 2011 [PubMed: 20824320] Study does not meet protocol eligibility criteria - treatments included vaginal antibiotics for bacterial vaginosis/abnormal flora (RCT evidence available).
Krauss-silva, L., Moreira, M. E. L., Alves, M. B., Braga, A., Camacho, K. G., Batista, M. R. R., Almada-horta, A., Rebello, M. R., Guerra, F., Randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: Preliminary results, Trials, 239, 2011 [PMC free article: PMC3264514] [PubMed: 22059409] Study does not meet protocol eligibility criteria - women with symptomatic vaginal discharge were excluded; probiotics not a relevant intervention for bacterial vaginosis.
Lamont,R.F., Nhan-Chang,C.L., Sobel,J.D., Workowski,K., Conde-Agudelo,A., Romero,R., Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis, American Journal of Obstetrics and Gynecology, 205, 177–190, 2011 [PMC free article: PMC3217181] [PubMed: 22071048] Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Larsson,P.G., Fahraeus,L., Carlsson,B., Jakobsson,T., Forsum,U., Late miscarriage and preterm birth after treatment with clindamycin: A randomised consent design study according to Zelen, BJOG: An International Journal of Obstetrics and Gynaecology, 113, 629–637, 2006 [PubMed: 16709205] Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Larsson,P.G., Fahraeus,L., Carlsson,B., Jakobsson,T., Forsum,U., Predisposing factors for bacterial vaginosis, treatment efficacy and pregnancy outcome among term deliveries; results from a preterm delivery study, BMC Women’s Health, 7, 20-, 2007 [PMC free article: PMC2186314] [PubMed: 17953762] Study population does not meet protocol eligibility criteria - unclear whether symptomatic pregnant women.
Laue, C., Papazova, E., Liesegang, A., Pannenbeckers, A., Arendarski, P., Linnerth, B., Domig, K. J., Kneifel, W., Petricevic, L., Schrezenmeir, J., Effect of a yoghurt drink containing Lactobacillus strains on bacterial vaginosis in women - a double-blind, randomised, controlled clinical pilot trial, Beneficial MicrobesBenef Microbes, 9, 35–50, 2018 [PubMed: 29065710] Study does not meet protocol eligibility criteria - pregnant women were excluded; probiotics not a relevant intervention for bacterial vaginosis.
Lebherz, T. B., Ford, L. C., Candida albicans vaginitis: the problem is diagnosis, the enigma is treatment, ChemotherapyChemotherapy, 28Suppl 1, 73–9, 1982 [PubMed: 6761087] Study populations do not meet protocol eligibility criteria - 2 studies reported; one does not state pregnant women with symptomatic vaginal discharge; second study mainly non-pregnant women.
Lee,J.E., Han,J.Y., Choi,J.S., Ahn,H.K., Lee,S.W., Kim,M.H., Ryu,H.M., Yang,J.H., Nava-Ocampo,A.A., Koren,G., Pregnancy outcome after exposure to the probiotic Lactobacillus in early pregnancy, Journal of Obstetrics and Gynaecology, 32, 227–229, 2012 [PubMed: 22369393] Study population does not meet protocol eligibility criteria - indications for probiotics were not reported.
Leitich,H., Brunbauer,M., Bodner-Adler,B., Kaider,A., Egarter,C., Husslein,P., Antibiotic treatment of bacterial vaginosis in pregnancy: a meta-analysis, American Journal of Obstetrics and Gynecology, 188, 752–758, 2003 [PubMed: 12634652] Systematic review includes studies of asymptomatic population
Mahmoudabadi,A.Z., Najafyan,M., Moghimipour,E., Alwanian,M., Seifi,Z., Lamisil versus clotrimazole in the treatment of vulvovaginal candidiasis, Iranian Journal of Microbiology, 5, 86–90, 2013 [PMC free article: PMC3577561] [PubMed: 23466900] Study population does not meet protocol eligibility criteria - Pregnant women were excluded from the study.
Mainini, G., Scaffa, C., First-line treatment of bacterial and mycotic vulvovaginitis with a new topical medication based on lipohydroperoxides and glycyrrhetic acid, International Journal of Gynecology and Obstetrics, 2), S255, 2009 [PubMed: 21995156] Study design does not meet protocol eligibility criteria - conference abstract.
Mann,J.R., McDermott,S., Zhou,L., Barnes,T.L., Hardin,J., Treatment of trichomoniasis in pregnancy and preterm birth: An observational study, Journal of Women’s Health, 18, 493–497, 2009 [PubMed: 19361316] Study population does not meet protocol eligibility criteria - unclear whether pregnant women had symptomatic vaginal discharge.
McDonald, H. M., O’Loughlin, J. A., Vigneswaran, R., Jolley, P. T., Harvey, J. A., Bof, A., McDonald, P. J., Metronidazole treatment of bacterial vaginosis flora and its effect on preterm birth, International journal of STD & AIDS, 8, 37–38, 1997 not symptomatic
McMillan, A., Rulisa, S., Gloor, G. B., Macklaim, J. M., Sumarah, M., Reid, G., Pilot assessment of probiotics for pregnant women in Rwanda, PLoS ONE, 13, 2018 [PMC free article: PMC6005520] [PubMed: 29912913] Study does not meet protocol eligibility criteria - indications for probiotics were not reported.
Mendling, W., Caserini, M., Palmieri, R., A Randomised, controlled study to assess the efficacy and safety of nifuratel vaginal tablets on bacterial vaginosis, Sexually Transmitted Infections. Conference: STI and AIDS World Congress, 89, 2013 Study design does not meet protocol eligibility criteria - conference abstract.
Milne, L. J., Brown, A. D., Comparison of nystatin (‘Nystan’) and hydrargaphen (‘Penotrane’) in the treatment of vaginal candidosis in pregnancy, Curr Med Res OpinCurrent medical research and opinion, 1, 524–7, 1973 [PubMed: 4591821] Study population does not meet protocol eligibility criteria - unclear whether pregnant women had symptomatic vaginal discharge.
Mitchell,C., Balkus,J., Agnew,K., Lawler,R., Hitti,J., Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy, Journal of Women’s Health, 18, 1817–1824, 2009 [PMC free article: PMC2864467] [PubMed: 19951217] Study population does not meet protocol eligibility criteria - unclear whether women had symptomatic vaginal discharge.
Mitchell,C.M., Hitti,J.E., Agnew,K.J., Fredricks,D.N., Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria, BMC Infectious Diseases, 9, 89-, 2009 [PMC free article: PMC2703644] [PubMed: 19515236] Study population does not meet protocol eligibility criteria - asymptomatic.
Morales,W.J., Schorr,S., Albritton,J., Effect of metronidazole in patients with preterm birth in preceding pregnancy and bacterial vaginosis: a placebo-controlled, double-blind study, American Journal of Obstetrics and Gynecology, 171, 345–347, 1994 [PubMed: 8059811] Population is women with history of preterm birth who will be on different treatment pathway (covered by NICE guideline NG25)
Morency, A. M., Bujold, E., The Effect of Second-Trimester Antibiotic Therapy on the Rate of Preterm Birth, Journal of Obstetrics and Gynaecology Canada, 29, 35–44, 2007 [PubMed: 17346476] Systematic review - included studies not specifically in pregnant women with conditions of interest.
Nct,, Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery, Https:​//clinicaltrials​.gov/show/nct00491270, 2007 Clinical trial record, no results posted and no related publications reported.
Nct,, Clindamycin to Reduce Preterm Birth in a Low Resource Setting, Https:​//clinicaltrials​.gov/show/nct01800825, 2013 Clinical trial record - no results posted.
Nct,, Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies, Https:​//clinicaltrials​.gov/show/nct01722708, 2012 Clinical trial record, no results posted and no related publications reported.
Nct,, Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes, Https:​//clinicaltrials​.gov/show/nct01421615, 2011 Clinical trial record, no results posted and no related publications reported; no comparator group.
Nct,, Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis, Https:​//clinicaltrials​.gov/show/nct03473418, 2018 Clinical trial record, no results posted; non-English language related publication.
Nct,, LACTIN-V Study for Recurrent Bacterial Vaginosis, Https:​//clinicaltrials​.gov/show/nct02766023, 2016 Clinical trial record, no results posted and no related publications reported.
Nct,, Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy, https://clinicaltrials.gov/show/NCT00153517, 2005 Study outcomes did not meet eligibility criteria - assessed BV-associated
Nct,, Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study, Https:​//clinicaltrials​.gov/show/nct02795845, 2016 Clinical trial record, no results posted and no related publications reported.
Nct,, Patients With Vulvovaginal Candidiasis, Https:​//clinicaltrials​.gov/show/nct03024502, 2017 Clinical trial record - no results posted and no relevant publications presented.
Nct,, Pregnancy Complications - A Probiotic Interventional Study, Https:​//clinicaltrials​.gov/show/nct02693041, 2016 Study population does not meet protocol eligibility criteria - not specifically the three conditions of interest.
Nct,, Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis, Https:​//clinicaltrials​.gov/show/nct00642980, 2008 Clinical trial record, no results posted.
Nct,, Probiotic for Vaginal Candidiasis in Pregnant Women, https://clinicaltrials.gov/show/NCT03940612, 2019 Study does not report results (clinical trial record only) (VC in pregnant women treated with probiotic vs placebo, outcomes frequency of symptoms)
Nct,, Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy, Https:​//clinicaltrials​.gov/show/nct01558388, 2012 Clinical trial record, no results posted and no related publications reported.
Nct,, Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity, https://clinicaltrials.gov/show/NCT03954990, 2019 Study population does not meet eligibility criteria - women in active labour diagnosed with bacterial vaginosis (compares metronidazole vs placebo). Clinical trials record
Nct,, Treatment of ppROM With Erythromycin vs. Azithromycin Trial, Https:​//clinicaltrials​.gov/show/nct03060473, 2017 Clinical trial record, no results posted and no related publications reported.
Nct,, Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery, Https:​//clinicaltrials​.gov/show/nct01152528, 2010 Clinical trial - single treatment arm; intervention does not meet protocol eligibility criteria.
Nordqvist, M., Jacobsson, B., Brantsaeter, A. L., Myhre, R., Nilsson, S., Sengpiel, V., Timing of probiotic milk consumption during pregnancy and effects on the incidence of preeclampsia and preterm delivery: A prospective observational cohort study in Norway, BMJ Open, 8 (1) (no pagination), 2018 [PMC free article: PMC5780685] [PubMed: 29362253] Study population does not meet protocol eligibility criteria - indication for probiotic milk consumption was not reported and women were not reported to be infected with vaginal candidiasis.
Nurbhai, M., Grimshaw, J., Watson, M., Bond, C. M., Mollison, J. A., Ludbrook, A., Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush), Cochrane Database of Systematic Reviews, 2007 [PubMed: 17943774] Cochrane review - study population does not meet protocol eligibility criteria (pregnant women excluded from the review).
Nygren,P., Fu,R., Freeman,M., Bougatsos,C., Klebanoff,M., Guise,J.M., Evidence on the benefits and harms of screening and treating pregnant women who are asymptomatic for bacterial vaginosis: An update review for the U.S. Preventive Services Task Force, Annals of Internal Medicine, 148, 220–233, 2008 [PubMed: 18252684] Systematic review - study population does not meet protocol eligibility criteria (asymptomatic women).
Nyirjesy, P., Robinson, J., Mathew, L., Lev-Sagie, A., Reyes, I., Culhane, J. F., Alternative therapies in women with chronic vaginitis, Obstetrics & GynecologyObstet Gynecol, 117, 856–61, 2011 [PubMed: 21422856] Study does not meet protocol eligibility criteria - not all women reported discharge and vaginal candidiasis; outcomes not reported separately in treatments of interest (all complimentary and alternative medicine grouped together).
Okun, N., Gronau, K. A., Hannah, M. E., Antibiotics for bacterial vaginosis or Trichomonas vaginalis in pregnancy: a systematic review, Obstetrics & Gynecology, 105, 857–68, 2005 [PubMed: 15802417] Systematic review includes studies of asymptomatic population
Othman, M., Alfirevic, Z., Neilson, J. P., Probiotics for preventing preterm labour, Cochrane Database of Systematic Reviews, 2007 [PMC free article: PMC9006117] [PubMed: 17253567] Cochrane review - included studies checked for relevance.
Ovalle,A., Romero,R., Gomez,R., Martinez,M.A., Nien,J.K., Ferrand,P., Aspillaga,C., Figueroa,J., Antibiotic administration to patients with preterm labor and intact membranes: is there a beneficial effect in patients with endocervical inflammation?, Journal of Maternal-Fetal and Neonatal Medicine, 19, 453–464, 2006 [PubMed: 16966109] Study population does not meet protocol eligibility criteria - unclear whether women symptomatic for bacterial vaginosis.
Pikuza, V. V., Chilova, R. A., Ishchenko, A. I., Comparison of clinical efficacy and safety of domestic generic and original fluconazoles in the treatment of pregnant women with vulvovaginal candidiasis, Antibiotiki i khimioterapiia = antibiotics and chemoterapy [sic], 53, 35–37, 2008 [PubMed: 19227122] Study design does not meet protocol eligibility criteria - non-English language article (Russian).
Qualey, J. R., Cooper, C., Monistat cream (miconazole nitrate) a new agent for the treatment of vulvovaginal candidiasis, J Reprod MedThe Journal of reproductive medicine, 15, 123–5, 1975 [PubMed: 765457] Study population did not meet protocol eligibility criteria - unclear whether pregnant women had symptomatic vaginal discharge.
Rasti, S., Asadi, M. A., Taghriri, A., Behrashi, M., Mousavie, G., Vaginal candidiasis complications on pregnant women, Jundishapur Journal of MicrobiologyJundishapur j, 7, e10078, 2014 [PMC free article: PMC4138689] [PubMed: 25147665] Study design does not meet protocol eligibility criteria - letter to the Editor.
Reboucas, K. F., Eleuterio, J., Jr., Peixoto, R. C., Costa, A. P. F., Cobucci, R. N., Goncalves, A. K., Treatment of bacterial vaginosis before 28 weeks of pregnancy to reduce the incidence of preterm labor, International Journal of Gynaecology & ObstetricsInt J Gynaecol Obstet, 146, 271–276, 2019 [PubMed: 31022300] Systematic review includes studies of asymptomatic population
Rickard,K.L., Roberts,C.L., Kotsiou,G., Morris,J.M., Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: An openlabel pilot randomised controlled trial, Journal of Paediatrics and Child Health, 47, 10-, 2011 [PMC free article: PMC3063235] [PubMed: 21396090] Study design does not meet protocol eligibility criteria - conference abstract.
Roberts, C. L., Algert, C. S., Rickard, K. L., Morris, J. M., Treatment of vaginal candidiasis for the prevention of preterm birth: A systematic review and meta-analysis, Systematic Reviews, 4 (1) (no pagination), 2015 [PMC free article: PMC4373465] [PubMed: 25874659] Systematic review: included studies do not meet protocol eligibility criteria (asymptomatic pregnant women).
Roberts,C.L., Rickard,K., Kotsiou,G., Morris,J.M., Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial, BMC Pregnancy and Childbirth, 11, 18-, 2011 [PMC free article: PMC3063235] [PubMed: 21396090] Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Sandeford, J., Nippita, T., Morris, J., Seeho, S., The pro-pprom trial: randomised controlled trial of oral probiotic therapy for women with preterm prelabour rupture of membranes to prolong pregnancy duration, Journal of paediatrics and child health. Conference: 21st annual congress of the perinatal society of australia and new zealand, PSANZ. Australia, 53, 87, 2017 Study design does not meet protocol eligibility criteria - conference abstract.
Sangkomkamhang, U. S., Lumbiganon, P., Prasertcharoensuk, W., Laopaiboon, M., Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery, Cochrane Database of Systematic Reviews, 2, CD006178, 2015 [PMC free article: PMC8498019] [PubMed: 25922860] Cochrane review - included study population does not meet protocol eligibility criteria (aymptomatic pregnant women).
Schwebke, J. R., Marrazzo, J., Beelen, A. P., Sobel, J. D., A phase 3, multicenter, randomized, double-blind, vehicle-controlled study evaluating the safety and efficacy of metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis, Sexually transmitted diseases, 42, 376–381, 2015 [PMC free article: PMC4463027] [PubMed: 26222750] Study population does not meet protocol eligibility criteria - Pregnant women were excluded from the study.
Shennan,A., Crawshaw,S., Briley,A., Hawken,J., Seed,P., Jones,G., Poston,L., A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: the PREMET Study, BJOG: An International Journal of Obstetrics and Gynaecology, 113, 65–74, 2006 [PubMed: 16398774] Study population does not meet protocol eligibility criteria - asymptomatic pregnant women.
Sobel, R., Sobel, J. D., Metronidazole for the treatment of vaginal infections, Expert Opinion on Pharmacotherapy, 16, 1109–1115, 2015 [PubMed: 25887246] Study design does not meet protocol eligibility criteria - narrative review.
Steele, R. W., Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis, Clinical Pediatrics, 35, 378–9, 1996 [PubMed: 8829012] Study design does not meet eligibility criteria - a commentary on a published article
Subtil, D., Brabant, G., Tilloy, E., Devos, P., Canis, F., Fruchart, A., Bissinger, M. C., Dugimont, J. C., Nolf, C., Hacot, C., Gautier, S., Chantrel, J., Jousse, M., Desseauve, D., Plennevaux, J. L., Delaeter, C., Deghilage, S., Personne, A., Joyez, E., Guinard, E., Kipnis, E., Faure, K., Grandbastien, B., Ancel, P. Y., Goffinet, F., Dessein, R., Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial, The Lancet., 2018 [PubMed: 30322724] Study population does not meet eligibility criteria - asymptomatic women
Subtil,D., Brabant,G., Tilloy,E., Salleron,J., Canis,F., Fruchart,A., Bissinger,M.C., Dugimont,J.C., Catherine,N., Chantrel,J., Jousse,M., Desseauve,D., Plennevaux,J.L., Christine,D., Deghilage,S., Personne,A., Emmanuelle,J., Dessein,R., Goffinet,F., Early clindamycin for bacterial vaginosis in low-risk pregnancy: the PREMEVA1 randomized, multicenter, double-blind, placebo-controlled trial, American Journal of Obstetrics and Gynecology, 210, S3-, 2014 Study design does not meet protocol eligibility criteria - Conference abstract.
Sungkar,A., Purwosunu,Y., Aziz,M.F., Pratomo,H., Sutrisna,B., Sekizawa,A., Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate, International Journal of Gynaecology and Obstetrics, 117, 264–267, 2012 [PubMed: 22445423] Study comparison does not meet protocol eligibility criteria - comparison between test and treatment of bacterial vaginosis and usual antenatal care. There was no separate analysis of outcomes for women who received metronidazole only.
Tan, C. G., Good, C. S., Milne, L. J., Loudon, J. D., A comparative trial of six day therapy with clotrimazole and nystatin in pregnant patients with vaginal candidiasis, Postgrad Med JPostgraduate medical journal, 50Suppl 1, 102–5, 1974 [PubMed: 4467158] Study population does not meet protocol eligibility criteria - unclear whether women symptomatic vaginal discharge (candida confirmed by culture from high vaginal swab).
Thinkhamrop, J., Hofmeyr, G. J., Adetoro, O., Lumbiganon, P., Ota, E., Antibiotic prophylaxis during the second and third trimester to reduce adverse pregnancy outcomes and morbidity, Cochrane Database of Systematic Reviews, CD002250, 2015 [PubMed: 25621770] Systematic review: included studies do not meet protocol eligibility criteria - prophylaxis antibiotics.
Turner, A. N., Carr Reese, P., Fields, K. S., Anderson, J., Ervin, M., Davis, J. A., Fichorova, R. N., Roberts, M. W., Klebanoff, M. A., Jackson, R. D., A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis, American Journal of Obstetrics and Gynecology, 211, 479.e1–479.e13, 2014 [PMC free article: PMC4254061] [PubMed: 24949544] Study intervention does not meet protocol eligibility criteria - high-dose vitamin D.
Ugwumadu, A., Reid, F., Hay, P., Manyonda, I., Jeffrey, I., Oral clindamycin and histologic chorioamnionitis in women with abnormal vaginal flora, Obstetrics & GynecologyObstet Gynecol, 107, 863–8, 2006 [PubMed: 16582124] Substudy of Ugwumadu 2003 RCT (which was included in Brocklehurst 2013 SR); population does not meet protocol eligibility criteria - pregnant women with asymptomatic abnormal vaginal flora.
Ulbricht, Catherine, Budiman, Tantri, Chao, Wendy, Tanguay-Colucci, Shaina, Conquer, Julie, Costa, Dawn, Isaac, Richard, Parriott, Joseph, Randhawa, Amarita, Rusie, Erica, Grimes Serrano, Jill M., Varghese, Minney, Woods, Jen, Zhou, Sara, Probiotics (Bifidobacterium, Lactobacillus, and Saccharomyces boulardii): An Evidence-Based Systematic Review by the Natural Standard Research Collaboration, Alternative & Complementary Therapies, 17, 334–348, 2011 Systematic review - included studies checked (no evidence on probiotics for the treatment of vaginal candidiasis).
van Schalkwyk, J., Yudin, M. H., Allen, V., Bouchard, C., Boucher, M., Boucoiran, I., Caddy, S., Castillo, E., Kennedy, V. L., Money, D. M., Murphy, K., Ogilvie, G., Paquet, C., van Schalkwy, J. K., Vulvovaginitis: screening for and management of trichomoniasis, vulvovaginal candidiasis, and bacterial vaginosis, Journal of obstetrics and gynaecology Canada : JOGC = Journal d’obstetrique et gynecologie du Canada : JOGC, 37, 266–276, 2015 [PubMed: 26001874] Clinical practice guidelines.
Varma, R., Gupta, J. K., Antibiotic treatment of bacterial vaginosis in pregnancy: multiple meta-analyses and dilemmas in interpretation, European Journal of Obstetrics, Gynecology, & Reproductive Biology, 124, 10–4, 2006 [PubMed: 16129546] Systematic review: included studies checked for relevancy.
Wynn, A., Ramogola-Masire, D., Gaolebale, P., Moshashane, N., Agatha Offorjebe, O., Arena, K., Klausner, J. D., Morroni, C., Acceptability and Feasibility of Sexually Transmitted Infection Testing and Treatment among Pregnant Women in Gaborone, Botswana, 2015, BioMed Research International, 2016 (no pagination), 2016 [PMC free article: PMC4826911] [PubMed: 27119076] Study does not meet protocol eligibility criteria - unclear whether women were asymptomatic; outcome data not reported separately in women treated with metronidazole for vaginal trichomoniasis.
Young, G., Jewell, D., Topical treatment for vaginal candidiasis (thrush) in pregnancy, Cochrane Database of Systematic Reviews, 2001 [PubMed: 11687074] Cochrane review â□“ studies checked for eligibility: included Rubin 1980 and Ruiz-Velasco 1978, no other relevant articles.

Economic studies

One excluded list was created for all economic studies in this guideline. See supplementary material 2 for further information.

Appendix L. Research recommendations

Research recommendations for review question: What interventions are effective in treating symptomatic vaginal discharge due to infection as a result of bacterial vaginosis, vaginal trichomoniasis, or vaginal candidiasis during pregnancy?

No research recommendations were made for this review question.

Final

Evidence reviews underpinning recommendations 1.4.10 to 1.4.14

These evidence reviews were developed by the National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK573944PMID: 34524754

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