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O’Donnell A, McParlin C, Robson SC, et al. Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment. Southampton (UK): NIHR Journals Library; 2016 Oct. (Health Technology Assessment, No. 20.74.)

Cover of Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment.

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Chapter 12Clinical effectiveness: intravenous fluids

Introduction

Two studies compared the effectiveness of i.v. fluids for the treatment of women with HG.69,108 One trial by Tan and colleagues108 tested different compositions of i.v. solution (dextrose plus saline vs. saline only)108 and was judged as low risk of bias. The other study compared the use of diazepam against i.v. fluids containing vitamins69 but was judged as carrying an unclear risk of bias due to lack of sufficient information in a number of areas. Both papers described the trial participants as suffering from HG; however, we classified severity as either moderate,69 or moderate to severe108 based on the participant data provided. As previously described (see Chapter 3, Meta-analysis of included randomised controlled trials), given the differences between trials in patient populations, settings, interventions and, in particular, the heterogeneous nature of the reported outcomes across trials, we did not attempt to perform meta-analyses and have thus reported a narrative summary only for each intervention and comparator set. A summary of study conduct and results is depicted in Table 16, with safety data reported in Appendix 8.

TABLE 16. Results for i.

TABLE 16

Results for i.v. fluid interventions for NVP and HG

Dextrose saline versus saline only

Combined severity score

No combined score reported.

Nausea outcomes

The 10-point VAS was used by Tan and colleagues108 to assess nausea in their trial comparing dextrose plus saline versus saline only i.v. fluids. Although the difference after 24 hours between groups was not found to be significant [dextrose plus saline, VAS score = 2 (SD 1–4), saline only, VAS score = 2 (SD 2–4); p = 0.39], repeated-measures of the analysis of variance for nausea scores detected a significantly greater reduction in favour of the dextrose plus saline preparation (p = 0.046).

Vomiting outcomes

Tan and colleagues108 measured number of episodes of emesis to assess vomiting outcomes and did not detect a difference in the median change in episodes between groups [both groups = 0 (IQR 0–2); p = 0.66].

Retching outcomes

No independent retching scores reported.

Safety outcomes

Tan and colleagues108 did not report any pregnancy outcomes or side effects. No specific UKTIS data were available on this intervention.

Intravenous fluids versus intravenous fluids plus diazepam

Combined severity score

No combined score presented.

Nausea outcomes

For patients with a nausea score of 4+ (classed by the authors as severe nausea), significant reductions for both groups were found on the second and third days of therapy using the VAS (p < 0.05) in the trial of Ditto and colleagues69 They reported that on day 2, this reduction was significantly greater in the diazepam group (p < 0.002); however, post treatment, the difference between groups was not significant (no p-value reported).

Vomiting outcomes

Ditto and colleagues69 assessed vomiting outcomes via number of vomiting episodes. No significant difference between groups was observed (exact p-value not provided).

Retching outcomes

No independent retching outcomes reported.

Safety outcomes

No side effects were reported in the trial of Ditto and colleagues,69 and no statistically significant differences were reported in terms of gestation at delivery; preterm delivery; caesarean section rate; mean birthweight or neonatal abnormalities (p-value not reported). As above, no specific UKTIS data were available on this intervention.

Summary

  • The evidence available for i.v. fluids was at low108 or unclear69 risk of bias.
  • i.v. fluid improves reported symptoms. Dextrose saline may be more effective at improving nausea over time for those with moderate nausea.
  • Diazepam appears to be more effective than i.v. fluids alone at reducing nausea on day 2 but there was no evidence post treatment for those with moderate/severe nausea.
  • Overall, i.v. fluids help correct dehydration and improve symptoms, dextrose saline may be more effective at reducing nausea than normal saline. (The lower concentration of sodium in dextrose saline may exacerbate any pre-existing hyponatraemia. High doses/concentrations of dextrose solutions may increase the risk of Wernicke’s encephalopathy, but concentrations in dextrose saline are unlikely to provoke this response.)
  • Future studies are required which focus on interventions given alongside rehydration therapy.
Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by O’Donnell et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK390541

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