Healthy Pregnancy Program

The standard of care for pregnant women using prescription painkillers or heroin is maintenance treatment with opioid addiction medications methadone or buprenorphine. Abstaining from drugs without medication is not recommended because of the high risk to the mother of relapse and overdose. While most programs fail to provide care for this population, we have developed a program specifically for this under-served group. Our Healthy Pregnancy Program utilizes the holistic and multi-disciplinary program provided by MIA while working with your Obstetrician to ensure a healthy delivery.

Although methadone and buprenorphine expose the fetus to low doses of opioids, the risk to the newborn of withdrawal symptoms is far outweighed by the risk of a fatal overdose when pregnant women receive no treatment or attempt to abstain from drugs without medication.

Abruptly quitting opioids in the first and third trimesters of pregnancy can cause harm to the fetus, including miscarriage and stillbirth, and is not recommended. Even in the second trimester, specialists agree that the risk of relapse outweighs any potential benefit to the fetus of lowering the dose of addiction maintenance medications or discontinuing their use.

Until recently, data on use of buprenorphine in pregnancy were relatively limited (25). A 2010 multicenter, randomized clinical trial compared the neonatal effects of buprenorphine and methadone in 175 opioid-dependent gravid women (26). In that study, the buprenorphine-exposed neonates required, on average, 89% less morphine to treat neonatal abstinence syndrome, a 43% shorter hospital stay, and a 58% shorter duration of medical treatment for neonatal abstinence syndrome (26). These results support the use of buprenorphine as a potential first-line medication for pregnant opioid-dependent women who are new to treatment. It is important to understand that buprenorphine will not be effective for all patients.

Women who become pregnant while already undergoing a treatment with a stable co-formulated buprenorphine dosage generally are advised to continue the same dosage but to transition to the single-agent product. The indications for the use of buprenorphine during pregnancy are in flux currently. Previous recommendations have limited use of buprenorphine to women who have refused to use methadone, have been unable to take methadone, or those for whom methadone treatment was unavailable. The current trend is moving toward considering a patient as a potential candidate for buprenorphine if she prefers buprenorphine to methadone, gives informed consent after a thorough discussion of relative risks and benefits, and is capable of adherence and safe self-administration of the medication. If the pregnant woman is receiving methadone therapy, she should not consider transitioning to buprenorphine because of the significant risk of precipitated withdrawal. The potential risk of unrecognized adverse long-term outcomes, which is inherent with widespread use of relatively new medications during pregnancy, should always be taken into consideration.

Medically supervised withdrawal from opioids in opioid-dependent women is not recommended during pregnancy because the withdrawal is associated with high relapse rates (27). However, if methadone maintenance is unavailable or if women refuse to undergo methadone or buprenorphine maintenance, medically supervised withdrawal should ideally be undertaken during the second trimester and under the supervision of a physician experienced in perinatal addiction treatment (13). If the alternative to medically supervised withdrawal is continued illicit drug use, then a medically supervised withdrawal in the first trimester is preferable to waiting until the second trimester.

It is important that frequent communication be maintained between the patient’s obstetric care provider and the addiction medicine provider to coordinate care. The federal confidentiality law 42 CFR Part 2 applies to addiction treatment providers. Patient information release forms with specific language regarding substance use are required (28).

BUPRENORPHINE OR METHADONE? — Programs treating opioid-dependent pregnant women in the United States use either methadone or buprenorphine as first-line therapy. In 2012, the American College of Obstetricians and Gynecologists (ACOG) concluded that the available evidence “supports the use of buprenorphine as a potential first-line medication for pregnant opioid-dependent women who are new to treatment” [1]. As a result of the ACOG opinion and increasing data suggesting a lower rate of neonatal withdrawal with buprenorphine use, use of buprenorphine for opioid maintenance therapy during pregnancy has been increasing [4,5]. However, the improvement in neonatal outcome may relate to differences in baseline characteristics between women who are offered methadone or buprenorphine treatment [5]. (See ‘Neonatal abstinence syndrome’ below.)

Comprehensive treatment. It is necessary for women to engage in treatment programs that offer all of the following at a single site: opioid-substitution therapy, psychiatry and social worker services, individual and group counseling, and case management. Clinicians prescribing buprenorphine in office-based settings are required to have the capacity to refer the patient for counseling, but not required to provide counseling on-site.

The largest trial in the systematic review was the landmark Maternal Opioid Treatment: Human Experimental Research (MOTHER) trial, which included 175 pregnant women with opioid dependency randomly assigned to treatment with methadone or buprenorphine at eight international sites [12]. Compared with methadone, buprenorphine therapy resulted in significantly lower doses of morphine for treatment of NAS (mean total 1.1 versus 10.4 mg), shorter duration of treatment for NAS (4.1 versus 9.9 days), and shorter neonatal hospital stay (10.0 versus 17.5 days). However, there were several limitations to this trial [13], including a statistically non-significant but markedly higher attrition rate from the buprenorphine treatment arm than from the methadone arm (33 versus 18 percent), which may have been due to the buprenorphine dosing protocol. The usual maximum dose of sublingual buprenorphine (32 mg daily) may not have been sufficient to prevent symptoms of withdrawal in some pregnant women (usually those requiring >140 mg methadone daily).

Your Child

Compared with infants born to non-opioid dependent women, neonates exposed to buprenorphine exhibit lower birthweight and smaller head circumference [15,16]. Several observational and randomized studies have demonstrated longer gestation, increased birthweight, and larger head circumference in buprenorphine-exposed versus methadone-exposed pregnancies [3,12]. These are interrelated variables (ie, larger head circumference is the result of later gestational age at birth) and most studies were limited in their ability to control for confounding factors (eg, prior obstetric history, smoking, etc). Other large studies have not consistently confirmed a difference in these outcomes [17,18].

There are few long-term neurodevelopmental studies of buprenorphine-exposed fetuses [18-21]. The lack of such studies documenting absence of adverse long-term effects should be discussed with women contemplating buprenorphine maintenance therapy [1]. Most of the available data come from small retrospective series lacking comparisons to existing treatments, untreated opioid-dependent women, or normal controls; therefore, the ability to address confounding factors is limited (especially exposure to other substances). Research on long-term neurodevelopmental outcome is further limited by high rates of attrition, heterogeneity in the methods of assessment, and length of follow-up.

●Cognitive and motor development

•One study (n = 21 children) reported lower scores on cognitive and language scales at three years of age in children exposed prenatally to maternal illicit buprenorphine use compared with non-exposed controls [19].

•A longitudinal study, which included 73 children evaluated at 24 months (n = 24 buprenorphine exposed, n = 19 methadone exposed, n = 30 non-exposed controls) found no differences between groups in neurological development or temperament during the first two years of life [18].

•A retrospective study observed that in utero exposure to maternal methadone dose >100 mg/day was associated with a reduction in infant head circumference compared with buprenorphine or lower dose methadone; it also appeared to have a negative impact on motor skill development during early infancy [22], but others have not confirmed this finding [23].

●Brain imaging and EEG

•A small series reported no structural or signal abnormalities on neonatal magnetic resonance imaging (MRI) in seven infants exposed in utero to buprenorphine substitution therapy [20].

•A small series reported no abnormalities on electroencephalography (EEG) (n = 9 neonates) or cranial ultrasound (n = 10 neonates) born to addicted women on buprenorphine substitution therapy [21].

●Psychosocial issues – A study of 102 neonates suggested that buprenorphine exposure is associated with a high rate of maltreatment, of which >50 percent was medical neglect (failure to bring the child to the pediatrician) [24].

Concerns about the effects of methadone on the developing visual system have been raised; buprenorphine exposure does not appear to confer this risk [25]. (See “Methadone maintenance therapy during pregnancy”.)

Additional Information about pregnancy and treatment:

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