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Maintenance agonist treatments for opiate dependent pregnant women

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Abstract

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Background

The prevalence of opiate use among pregnant women ranges from 1% to 2% to as much as 21%. Heroin crosses the placenta and pregnant opiate dependent women experience a six fold increase in maternal obstetric complications such as low birth weight, toxaemia, 3rd trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neurobehavioral problems, increased neonatal mortality and a 74‐fold increase in sudden infant death syndrome.

Objectives

To assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions on child health status, neonatal mortality, retaining pregnant women in treatment, and reducing use of substances

Search methods

We searched Cochrane Drugs and Alcohol Group' Register of Trials (June 2007), PubMed (1966 ‐ June 2007), CINAHL (1982‐ June 2007), reference lists of relevant papers, sources of ongoing trials, conference proceedings, National focal points for drug research. Authors of included studies and experts in the field were contacted.

Selection criteria

Randomised controlled trials enrolling opiate dependent pregnant women

Data collection and analysis

The authors assessed independently the studies for inclusion and methodological quality. Doubts were solved by discussion.

Main results

We found three trials with 96 pregnant women. Two compared methadone with buprenorphine and one methadone with oral slow morphine. For the women there was no difference in drop out rate RR 1.00 (95% CI 0.41 to 2.44) and use of primary substance RR 2.50 (95% CI 0.11 to 54.87) between methadone and buprenorphine, whereas oral slow morphine seemed superior to methadone in abstaining women from the use of heroin RR 2.40 (95% CI 1.00 to 5.77)
For the newborns in one trial buprenorphine performed better than methadone for birth weight WMD ‐530 gr (95% CI ‐662 to ‐397), this result is not confirmed in the other trial. For the APGAR score both studies didn't find significant difference . No differences for NAS measures used. Comparing methadone with oral slow morphine no differences for birth weight and mean duration of NAS. The APGAR score wasn't considered.

Authors' conclusions

We didn't find any significant difference between the drugs compared both for mother and for child outcomes; the trials retrieved were too few and the sample size too small to make firm conclusion about the superiority of one treatment over another. There is an urgent need of big randomised controlled trials.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

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Mantenance agonist tratments for opiate dependent pregnant women.

Some women continue to use opiates when they are pregnant. Yet heroin readily crosses the placenta. Opiate dependent women experience a six‐fold increase in maternal obstetric complications and give birth to low‐weight babies. The newborn may experience narcotic withdrawal (neonatal abstinence syndrome), have development problems, increased neonatal mortality and a 74‐fold increased risk of sudden infant death syndrome. Maintenance treatment with methadone provides a steady concentration of opiate in the pregnant woman's blood and so prevents the adverse effects on the fetus of repeated withdrawals. Buprenorphine is also used. They reduce illicit drug use, improve compliance with obstetric care and improve birth weight but are still associated with neonatal abstinence syndrome. The present review found few differences in newborn or maternal outcomes for pregnant opiate‐addicted women who were maintained on methadone, buprenorphine or oral slow morphine from a mean gestational age of 23 weeks to delivery. Only three randomised controlled trials satisfied the criteria for the review, two from Austria (outpatients) and one from the USA (inpatients). The trials continued for 15 to 18 weeks. Two compared methadone with buprenorphine (48 participants) and one compared methadone with oral slow morphine (48 participants). The number of women who dropped out from treatment and the use of primary substance appeared to be the same for methadone and buprenorphine. Oral slow morphine seemed superior to methadone for the number of women who used heroin in their third trimester but without a clear improvement in infant birth weight or duration of neonatal abstinence syndrome.The number of participants in the trials was very small and may not be sufficient to detect differences. Only one study reported on the number of cigarettes the women smoked, a mean of 29 cigarettes per day at enrolment and 14 cigarettes per day at delivery. All the included studies ended immediately after the baby was born. No severe complications were noted.