Following an extensive review of the evidence in each of the six scoping areas, the GDG agreed on the following recommendations for the identification and management of substance use and substance use disorders during pregnancy. Each recommendation is followed by remarks clarifying contextual issues and relevant aspects of management. During development of the recommendations, the GDG identified considerable research gaps and agreed on a list of research priorities and questions, which are listed after the recommendations.
Overarching principles
It was noted by the Guideline Development Group that certain principles apply to all the recommendations described below. These overarching principles are proposed to provide guidance in the process of planning, implementing and evaluating the most suitable and relevant recommendations according to the national contexts and available resources.
Prioritizing prevention.
Preventing, reducing and ceasing the use of alcohol and drugs during pregnancy and in the postpartum period are essential components in optimizing the health and well-being of women and their children.
This effort requires a multifaceted approach with multidisciplinary actions, including the right to accurate information about the risks of alcohol and drug use in pregnancy, a health-care system that implements prevention strategies and supports healthy choices about substance use among women of childbearing age, and health promotion efforts encouraging a healthy home and social environment, supporting pregnant women and their partners in making healthy choices about their substance use and protecting from pressures to drink alcohol or use drugs.
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Ensuring access to prevention and treatment services.
All pregnant women and their families affected by substance use disorders should have access to affordable prevention and treatment services and interventions delivered with a special attention to confidentiality, national legislation and international human rights standards; women should not be excluded from accessing health care because of their substance use.
Health-care services should be able to identify and manage substance use and substance use disorders in pregnancy. Substance use disorders should be identified by the health-care system at the earliest opportunity and quality, affordable and accessible treatment offered. Specialized services for women with substance use disorders should be recognized as an important component of the health system and need to be available proportional to the clinical need. Health-care services for women with substance use disorders should take into consideration the childcare needs of women when considering the accessibility of their services. Confidentiality, a fundamental right of every health-care user, is also affected by the organization of services.
- III.
Respecting patient autonomy.
The autonomy of pregnant and breastfeeding women should always be respected; women with substance use disorders need to be fully informed about the risks and benefits, for herself and for her fetus or infant, of available treatment options, when making decisions about her health care.
Patient autonomy and patient-centred care are crucial components of health-care services for pregnant women. Treatment decisions should be based on accepted principles of medical-care ethics, respecting a women's autonomy in decisions related to her care and the health of her fetus, and her right to privacy and confidentiality when discussing treatment options. It is essential to provide clear, accurate and consistent information to pregnant and breastfeeding women about the risks of alcohol and drug use, and all women with substance use disorders should have access to information about effective contraception.
- IV.
Providing comprehensive care.
Services for pregnant and breastfeeding women with substance use disorders should have a level of comprehensiveness that matches the complexity and multifaceted nature of substance use disorders and their antecedents.
Comprehensive services for pregnant and breastfeeding women include a range of gender-sensitive prevention and treatment interventions that can respond to multiple needs, including childcare needs, comorbid mental and concurrent medical conditions, bloodborne viruses and other infectious diseases, poor diet and psychosocial problems such as relationships with a partner/other people living in the same household, homelessness, poverty and violence. Comprehensive services that offer a continuity of care are generally much easier for vulnerable groups to access.
- V.
Safeguarding against discrimination and stigmatization.
Prevention and treatment interventions should be provided to pregnant and breastfeeding women in ways that prevent stigmatization, discrimination, marginalization, and promote family, community and social support as well as social inclusion by fostering strong links with available childcare, employment, education, housing and other relevant services.
Health-care providers should seek to establish a clinician-patient relationship without discrimination or stigmatization. All important information about the risks of substance use and the benefits of treatment should be communicated in a non-judgemental, respectful, non-stigmatizing and empathic manner, sensitive to age, culture and language differences. All important information has to be provided verbally, as well as in writing, at reading and comprehension levels that are congruent with the patient's level of literacy. Health-care providers should respond to disclosure of private and distressing information (e.g. gender-based violence or self-harm) with sensitivity.
Screening and brief interventions for hazardous and harmful substance use during pregnancy
(Evidence Profile 1: see Annex 1)
Much of the evidence underlying the effectiveness of screening and brief interventions during pregnancy comes from a period when reporting standards and measures of bias were not in standard use, hence the evidence quality is graded as low or very low. However, the evidence retrieved indicated that being asked about alcohol and other substance use in a detailed and comprehensive manner may increase a woman's awareness of the risks associated with alcohol and drug use and may function to modify her behaviour.
A brief motivational intervention has been found to reduce the number of drinks and the number of heavy drinking days during the postpartum period. Pregnant women with higher levels of alcohol use may reduce their alcohol use following a brief intervention that includes their partner.
Pregnant adolescent girls with a substance use disorder have been shown to reduce their substance use after a single-session, standardized brief intervention. Full details of studies evaluated, harms and benefits, feasibility and resource use are provided in Annex 1, page 22.
RECOMMENDATION 1
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| Health-care providers should ask all pregnant women about their use of alcohol and other substances (past and present) as early as possible in the pregnancy and at every antenatal visit. |
| Strength of recommendation: Strong | Quality of evidence: Low |
| Remarks:
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RECOMMENDATION 2
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| Health-care providers should offer a brief intervention to all pregnant women using alcohol or drugs. |
| Strength of recommendation: Strong | Quality of evidence: Low |
Remarks:
Brief intervention is a structured therapy of short duration (typically 5–30 minutes) offered with the aim of assisting an individual to cease or reduce the use of a psychoactive substance. It is designed in particular for general practitioners and other primary health-care workers. Health-care providers should be given appropriate training and resource materials. The brief intervention should be individualized, and include feedback and advice on ceasing or reducing alcohol and other substance use during pregnancy. There may need to be follow-up with the patient, with the possibility of referral to treatment for those patients who are unable to reduce or eliminate such use. The approach/attitude of health-care providers is an important contributor to the effectiveness of brief interventions. As for , it was decided that, despite the low quality of evidence of effectiveness, this should be a strong recommendation because the potential benefit – reduction of alcohol and/other substance use – likely outweighs any potential harms of a brief psychosocial intervention which were considered minimal. Therefore the balance of benefits versus harms was clearly positive, although there was uncertainty about the degree of benefit. In addition the burden of implementation was minimal.
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Psychosocial interventions for substance use disorders in pregnancy
(Evidence Profile 2: see Annex 1
The concept of “substance use disorders” includes dependence syndrome and harmful use of psychoactive substances such as alcohol, cannabis, amphetamine-type stimulants (ATS), cocaine, opioids and benzodiazepines. The evidence review sought trials evaluating the effectiveness of psychosocial interventions, including trials of cognitive behavioural therapy (CBT), motivational interviewing (MI), contingency management (CM), and home visits. All the trials were conducted in services specializing in the management of substance use in pregnancy. “Treatment-as-usual” in this context is best considered a form of unstructured psychosocial intervention rather than the absence of psychosocial support.
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Findings suggest that CBT may be superior to treatment-as-usual in terms of treatment retention, reductions in risky sex and needle use, and occurrence of preterm birth.
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Findings support the superiority of contingency management (CM) to treatment-as-usual in terms of retention in treatment, percentage of negative urines, and weeks of continuous cocaine abstinence.
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Findings do not support the superiority of MI to treatment-as-usual or educational control, with similar results for maternal retention in treatment and maternal substance abuse.
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A review of randomized trials suggests that increased home visits following delivery are not effective in reducing maternal substance use, or alcohol use, nor in improving adherence to substance abuse treatment.
RECOMMENDATION 3
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| Health-care providers managing pregnant or postpartum women with alcohol or other substance use disorders should offer comprehensive assessment and individualized care. |
| Strength of recommendation: Conditional | Quality of evidence: Very low |
| Remarks:
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Detoxification or quitting programmes for alcohol and other substance dependence in pregnancy
(Evidence Profile 3: see Annex 1)
A withdrawal syndrome requiring pharmacological treatment in pregnancy can be said to occur for three substances: benzodiazepines, alcohol, and opioids. The withdrawal syndrome associated with the cessation of other substances (such as psychostimulants) has not been considered to justify the use of psychotropic medication. For those pregnant women for whom medication-assisted withdrawal is successful, there does not appear to be any evidence of significant fetal distress during detoxification, no increased risk of fetal demise or premature delivery.
For opioid dependence, in addition to recommending cessation of opioid use, there is the option of prescribing long-acting opioids such as methadone and buprenorphine to maintain stable opioid levels (see also Evidence Profile 4 in Annex 1). Although this treatment approach includes a risk of neonatal opioid withdrawal symptoms, opioids are essentially non-toxic at stable levels. Cessation of opioids, on the other hand carries a higher risk of relapse to unstable patterns of short-acting opioid use (such as heroin). The decision, therefore, is between opioid maintenance treatment approach with a known risk of neonatal withdrawal but a low risk of relapse, and opioid detoxification, which, if successful, carries no risk of neonatal withdrawal, but, if unsuccessful, has a high risk of adverse neonatal outcomes, including neonatal opioid withdrawal and intrauterine growth retardation (IUGR) and also adverse maternal outcomes such as overdose.
For dependence on other substances, there was considered to be no feasible maintenance treatment option.
RECOMMENDATION 4
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| Health-care providers should, at the earliest opportunity, advise pregnant women dependent on alcohol or drugs to cease their alcohol or drug use and offer, or refer to, detoxification services under medical supervision where necessary and applicable. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Pregnant women dependent on alcohol or drugs who agree to undergo detoxification should be offered the supported withdrawal from substance use in an inpatient or hospital facility, if medically indicated. Detoxification can be undertaken at any stage in pregnancy, but at no stage should antagonists (such as naloxone, or naltrexone – in the case of opioid withdrawal) be used to accelerate the detoxification process. Equal attention should be paid to the health of mother and fetus during detoxification and treatment adjusted accordingly. It was decided that this recommendation should be strong, despite the very low quality of evidence of the effectiveness of the health-care intervention because there is clear evidence of harm to the fetus of ongoing maternal substance use, and the benefit to both mother and fetus of ceasing alcohol and/or substance use under medical supervision strongly outweighs any potential harms.
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RECOMMENDATION 5
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| Pregnant women dependent on opioids should be encouraged to use opioid maintenance treatment whenever available rather than to attempt opioid detoxification. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Such medication-assisted withdrawal from opioids should be attempted only in an inpatient unit, using a gradual reduction in methadone or buprenorphine doses. Inpatient care should also be considered for the initiation and optimization of maintenance treatment. Psychosocial treatment should be an integral component of such treatment. Pregnant women who fail to complete medication-assisted withdrawal should be offered opioid agonist pharmacotherapy. It was decided that this recommendation should be strong despite the low quality of evidence of effectiveness from randomized controlled trials, as the rate of relapse to opioid use following detoxification has been shown to be high and the risks of harm to both mother and fetus from failed detoxification are catastrophic compared to the very low risks of harm from opioid maintenance treatment.
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RECOMMENDATION 6
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| Pregnant women with benzodiazepine dependence should undergo a gradual dose reduction, using long-acting benzodiazepines. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Long-acting benzodiazepines should only be used for as short a time as is medically feasible in managing benzodiazepine withdrawal. Psychosocial interventions should be offered throughout the period of benzodiazepine withdrawal. It was decided that this recommendation should be strong despite the very low quality of evidence of effectiveness because ongoing benzodiazepine use in pregnancy is associated with significant risk of harm. At the same time, abrupt cessation of benzodiazepines can result in a severe withdrawal syndrome including seizures and psychosis. This leaves gradual reduction as the only practicable alternative. Significant clinical experience indicates that this approach is feasible and safe. Hence the GDG was in agreement that the benefits of gradual dose reduction outweigh the harms of both ongoing use and abrupt cessation.
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RECOMMENDATION 7
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| Pregnant women who develop withdrawal symptoms following the cessation of alcohol consumption should be managed with the short-term use of a long-acting benzodiazepine. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Management of alcohol withdrawal usually also includes administration of thiamine. Alcohol withdrawal management may be facilitated by the use of an alcohol-withdrawal scale such as the CIWA-Ar. Inpatient care should be considered in the withdrawal management of pregnant women with alcohol dependence. Alcohol withdrawal can be a severe and even life-threatening condition, provoking seizures and delirium. Evidence from non-pregnant populations has demonstrated the effectiveness of long-acting benzodiazepines for preventing seizures and delirium in alcohol withdrawal. Given the severity of alcohol withdrawal, and the lack of significant harm from short-term benzodiazepine use, and the evidence supporting the use of benzodiazepines in the management of alcohol withdrawal in the general population, the GDG decided that this recommendation should be strong despite the low quality of evidence in pregnant women.
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RECOMMENDATION 8
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| In withdrawal management for pregnant women with stimulant dependence, psychopharmacological medications may be useful to assist with symptoms of psychiatric disorders but are not routinely required. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Except for the management of acute intoxication, withdrawal management in amphetamine-type stimulants (ATS) dependence or cocaine dependence does not include psychopharmacological medications as a primary approach to treatment in pregnant patients. There is no evidence that medication-assisted withdrawal would benefit pregnant women with these respective disorders. Inpatient care should be considered in the withdrawal management of pregnant women with stimulant dependence. It was decided that this recommendation should be strong despite the very low quality of evidence because the harms to mother and fetus of ongoing use of psychostimulants use have been shown to be high. The risks of providing short-term appropriate non-teratogenic medications for short-term management of psychologically distressing symptoms in pregnancy are very low. Therefore, the potential benefits of this approach strongly outweigh the harms of providing psychopharmacological treatment of symptoms, if required, during psychostimulant withdrawal.
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Pharmacological treatment (maintenance and relapse prevention) for alcohol and other substance dependence in pregnancy
(Evidence Profile 4: see Annex 1)
Systematic reviews of psychopharmacological treatments, methadone versus buprenorphine and methadone compared to slow-release morphine for pregnant women with substance use disorders were performed and the evidence of effect evaluated (see GRADE tables and summary of findings tables in Annex 1 for full details). Findings in brief:
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Pharmacotherapy has been shown to be successful in the treatment of opioid dependence and benzodiazepine dependence. Methadone and buprenorphine have similar efficacy in the management of opioid dependnece. Methadone appears to result in better maternal retention in treatment, and buprenorphine is associated with some better neonatal outcomes, such as higher birthweight.
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Combining psychosocial interventions with pharmacotherapy has been shown to be superior to pharmacotherapy alone.
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No evidence was found on the use of medications for relapse prevention for alcohol dependence in pregnancy (acamprosate, disulfiram, nalmefene, naltrexone).
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No RCT evidence was found on the use of naltrexone in relapse prevention from opioid dependence in pregnancy.
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No evidence was found on the use of benzodiazepine maintenance for benzodiazepine dependence in pregnancy.
RECOMMENDATION 9
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| Pharmacotherapy is not recommended for routine treatment of dependence on amphetamine-type stimulants, cannabis, cocaine or volatile agents in pregnant patients. |
| Strength of recommendation: Conditional | Quality of evidence: Very low |
| Remarks:
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RECOMMENDATION 10
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| Given that the safety and efficacy of medications for the treatment of alcohol dependence has not been established in pregnancy, an individual risk benefit analysis should be conducted for each woman. |
| Strength of recommendation: Conditional | Quality of evidence: Very low |
| Remarks:
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RECOMMENDATION 11
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| Pregnant patients with opioid dependence should be advised to continue or commence opioid maintenance therapy with either methadone or buprenorphine. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Pregnant patients with opioid dependence should be encouraged to commence opioid agonist pharmacotherapy, which should be combined with psychosocial interventions. Opioid-dependent pregnant women who are already taking opioid maintenance therapy with methadone should not be advised to switch to buprenorphine due to the risk of opioid withdrawal. Pregnant opioid-dependent women taking buprenorphine should not be advised to switch to methadone unless they are not responding well to their current treatment. In opioid-dependent pregnant women, the buprenorphine mono formulation should be used in preference to the buprenorphine/naloxone formulation. Regardless of the choice of medication, psychosocial interventions should be an integral component of treatment. Opioid-dependent pregnant patients who wish to receive opioid antagonist pharmacotherapy should be discouraged from such a choice. It was decided that this recommendation should be strong despite the low quality of evidence as the rate of relapse to opioid use following detoxification is high and the risks of harm from failed detoxification are catastrophic compared to the small risks of harm from opioid maintenance treatment.
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Breastfeeding and maternal substance use
(Evidence Profile 5: see Annex 1)
Enhanced maternal-infant attachment through breastfeeding is especially important, particularly for women feeling guilty about their prenatal substance use and those who lack self-confidence in parenting skills. Breastfeeding and/or breast milk may reduce the incidence and/or severity of neonatal withdrawal syndrome in opioid-exposed infants.
Evidence of decreased stress response and increased vagal tone, indicating better autonomic regulation, in lactating compared to non-lactating women is salient for drug-dependent women. Stress can be a major factor in the development of psychiatric symptoms, and has been linked to relapse to substance use. Alcohol use, binge drinking, tobacco and marijuana use rates rebound substantially in the postpartum period compared with use during pregnancy. Depression correlates with substance use, and new mothers with postpartum depression may be at high risk for substance use or return to substance use. Maternal psychopathology is more common in substance-dependent women than in the general population, and is not infrequently related to poor judgment, enhancing the physical risk to the breastfed infant. Maternal somnolence, lack of adequate sleep-wake cycling, or decreased reaction times due to alcohol or drug use may increase the risk of infant injury.
RECOMMENDATION 12
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Mothers with substance use disorders should be encouraged to breastfeed unless the risks clearly outweigh the benefits. Breastfeeding women using alcohol or drugs should be advised and supported to cease alcohol or drug use; however, substance use is not necessarily a contraindication to breastfeeding.
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| Strength of recommendation: Conditional | Quality of evidence: Low |
Remarks:
A risk assessment should take into account the risks of exposure to alcohol and drugs in breast milk, HIV status, the specific pattern of substance use in each case, the availability of safe and affordable breast milk substitutes, as well as access to clean water, sterilizing equipment, and the age of the infant/child. Heavy daily alcohol consumption, such as in alcohol dependence, would constitute high risk to the infant, for example, and in the presence of safe breast milk alternatives, it would be preferable not to breastfeed. The message to breastfeeding women who have used alcohol and drugs to cease using alcohol and drugs while breastfeeding should be given in such a way that it does not undermine the potential benefits of breastfeeding. It is possible to reduce the risk of exposure through breastfeeding by altering the timing of breastfeeding, or by the use of temporary alternatives, such as stored (frozen) breast milk or breast milk substitutes where they are available and can be safely used. Women who use alcohol intermittently should be discouraged from breastfeeding for 2 hours after consuming one standard drink (10 g of pure alcohol), and 4–8 hours after consuming more than one drink in a single occasion. Breastfeeding advice for women with HIV should also take into consideration the risk of HIV transmission (refer to the WHO guidelines on breastfeeding and HIV). Mothers of infants with a neonatal withdrawal syndrome should be offered appropriate breastfeeding information and support. This recommendation was considered conditional because the different values and preferences of women and the lack of strong evidence of harms of low levels of substance use in pregnancy.
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RECOMMENDATION 13
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| Skin-to-skin contact is important regardless of feeding choice and needs to be actively encouraged for a mother with substance use disorder who is able to respond to her baby's needs. |
| Strength of recommendation: Strong | Quality of evidence: Low |
Remarks:
It was decided that the recommendation should be strong despite the very low quality evidence as the risk of harm is minimal, it consumes no resources, the values and preferences were in favour of the recommendation, and there was considered to be certainty about the balance between benefits and harms.
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RECOMMENDATION 14
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| Mothers who are stable on opioid maintenance treatment with either methadone or buprenorphine should be encouraged to breastfeed unless the risks clearly outweigh the benefits. |
| Strength of recommendation: Strong | Quality of evidence: Low |
Remarks:
Women prescribed opioids such as methadone and buprenorphine and wishing to stop breastfeeding should wean their children off breast milk gradually to reduce the risk of developing withdrawal symptoms. It was decided that the recommendation should be strong, as, despite the low quality of evidence of effect, it was considered highly likely that the benefit of avoiding withdrawal symptoms in the infant strongly outweighed any potential harms. The values and preferences expressed by end-users surveyed were strongly in favour of the recommendation and there was certainty about the balance between benefits and resources being consumed.
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Management of infants exposed to alcohol and other psychoactive substances
(Evidence Profile 6: see Annex 1)
Note: The term “neonatal withdrawal syndrome” is used here to remain consistent with WHO nomenclature, but the term “neonatal abstinence syndrome (NAS)” is commonly used with the same meaning.
The small study size and risk of bias in the studies evaluated mean that the evidence of treatment effectiveness is very uncertain. Protocols for the management of neonatal withdrawal syndrome have changed considerably over the last 40+ years. Initial treatment guidelines were weight-based, and tables for treatment with phenobarbital and paregoric were published. Current treatment involves use of an opioid such as morphine sulfate or tincture of opium, or a sedative, typically phenobarbital, with infrequent use of a benzodiazepine. Systems for scoring withdrawal are usually used to guide treatment initiation, maintenance and weaning. Because there is neither a uniform assessment method for measuring neonatal withdrawal nor an established treatment protocol, and health-care practices worldwide are variable, it is difficult to state with any precision how neonatal withdrawal is treated across the globe.
RECOMMENDATION 15
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| Health-care facilities providing obstetric care should have a protocol in place for identifying, assessing, monitoring and intervening, using non-pharmacological and pharmacological methods, for neonates prenatally exposed to opioids. |
| Strength of recommendation: Strong | Quality of evidence: Low |
Remarks:
Evidence of a dose-response relationship between opioid maintenance treatment and neonatal withdrawal syndrome has been inconsistent, which implies that all infants should be assessed. Infants exposed to opioids during pregnancy should remain in the hospital at least 4–7 days following birth and be monitored for neonatal withdrawal symptoms using a validated assessment instrument, which should be first administered 2 hours after birth and then every 4 hours thereafter. Non-pharmacological interventions including low lights, quiet environments, swaddling and skin-to-skin contact should be used with all neonates prenatally exposed to alcohol and drugs. It was decided that the recommendation should be strong despite the low quality of evidence of effect, as the GDG agreed that the benefits of such an approach strongly outweighed any potential harms. The values and preferences of end-users were in favour of the recommendation, and there was certainty that while resources would be consumed, the benefits strongly outweighed costs. There was a high value placed on identifying preventable suffering in affected neonates.
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RECOMMENDATION 16
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| An opioid should be used as initial treatment for an infant with neonatal opioid withdrawal syndrome if required. |
| Strength of recommendation: Strong | Quality of evidence: Very low |
Remarks:
Prolonged treatment of neonatal opioid withdrawal syndrome with opioids is generally not necessary and aiming for shorter treatment is preferable. Phenobarbital can be considered as an additional therapy if there has been concurrent use of other drugs in pregnancy, particularly benzodiazepines, and if symptoms of neonatal opioid withdrawal are not adequately suppressed by an opioid alone. If opioids are unavailable, phenobarbital can be used as an alternative therapy. Infants with signs of a neonatal withdrawal syndrome in the absence of known maternal opioid use should be fully assessed for possible benzodiazepine, sedative or alcohol exposure. The strong recommendation to use opioids rather than phenobarbital despite the very low quality of evidence of effectiveness was based on vast clinical experience with opioids in the management of both adult and neonatal opioid withdrawal. There has only been very limited clinical experience with phenobarbital use. In addition, the values and preferences of end-users were in favour of the recommendation, and the GDG agreed that there was certainty about the balance between benefits and resources being consumed.
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RECOMMENDATION 17
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| If an infant has signs of a neonatal withdrawal syndrome due to withdrawal from sedatives or alcohol or the substance the infant was exposed to is unknown, then phenobarbital may be a preferable initial treatment option. |
| Strength of recommendation: Conditional | Quality of evidence: Very low |
| Remarks:
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RECOMMENDATION 18
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| All infants born to women with alcohol use disorders should be assessed for signs of fetal alcohol syndrome. |
| Strength of recommendation: Conditional | Quality of evidence: Very low |
Remarks:
Signs of fetal alcohol syndrome (FAS) include growth impairment, dysmorphic facial features (short palpebral fissures, smooth or flattened philtrum, thin upper lip) and central nervous system abnormalities, including microcephaly. When assessing such infants the following information should be recorded: - –
birthweight and length - –
head circumference - –
dysmorphic facial features - –
gestation - –
prenatal exposure to alcohol - –
follow-up of infants with signs of FAS should be provided
This recommendation was considered conditional because of the lack of high-quality evidence, and questions about the feasibility of implementation in all settings.
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