Neonatal Outcomes of Women Who Conceive and Maintain on Methadone

1. Neonatal Outcomes of Women Who Conceive and Maintain on Methadone John McCarthy, M.D. Executive/Medical Director Bi-Valley Medical Clinic Sacramento, California

2. No Exit Conception in an opiate dependent state (street or prescribed opiates) causes fetal dependence and physiologic withdrawal is an unavoidable risk. • In the very earliest stages of pregnancy the risks are related more to uterine spasm and miscarriage, but at some point fetal physiologic dependence occurs. • Some degree of withdrawal will occur either in utero (where we can’t see it or monitor it well) or after birth (when we can see it and monitor it well).

3. Neonatal Abstinence Syndrome (NAS) vs. Intrauterine Abstinence Syndrome (IAS) NAS consists of neurologic, metabolic, and gastrointestinal symptoms following abrupt cessation of opiates at birth. • IAS are symptoms of opiate withdrawal during gestation, a difficult to assess and poorly understood state characterized by fetal motor and adrenergic hyperactivity. • NAS is treatable and studied, short and long term. IAS is treatable by raising the maternal dose. Studies of IAS are very limited: Zuspan increased epinephrine; Wong low blood flow.

4. What Are the Risks of Prolonged Methadone Exposure During Gestation, e.g. from Conception? • Does the duration, the timing, or the total amount of methadone exposure pose risks of more severe NAS or other complications? • Kemplova and Okruhlica (2000) compared 10 conceived/on babies to population controls and found no differences in BW, and GA. • Kandell (1976) found BW > heroin exposed but < community control. • Sharpe & Kushel (2004) studied 24 infants conceived on methadone and found “very little morbidity”, 58% Rx’d for NAS, GA 39 weeks.

5. Neonatal Outcomes of Babies Conceived and Maintained on Methadone (JSAT 2008) • The cohort is a subset of a larger group studied for the effects of high dose methadone on infant outcomes. • In order to try to accentuate differences in fetal methadone exposure we chose to compare a group who conceived and maintained thru the pregnancy (conceived-on N=22) with a group that were admitted to methadone in the 2nd or 3rd trimesters (conceived-off N=35). • Demographics: Caucasian 63%, Hispanic 25%, African American 5%, Asian American 5%, other 2%

8. Summary • Babies in the ‘conceived-on’ group were exposed to approximately 28.8 gms of methadone (110mg/day X 37.4 wks) vs 8.5 gms (93mg/day X 13.1 weeks) in the ‘conceived-off’ group, > 3 times the total methadone exposure. • Approximately 20 grams greater exposure for 24.3 weeks longer. • We found no significant differences in Rx for NAS, birth weight, length, gestational age, or days of hospitalization related to the timing, duration, or total dose of methadone.

9. Summary (con’t) • 49% of babies required meds for NAS, 45% in ‘conceived-on’ group. • 40% of the total sample breastfed for some period after delivery, 54% of the ‘conceived-on’ group. • Babies in the ‘conceived-on’ group were significantly less likely to be + for other drugs at delivery. • Although full term babies had normal BW, there was 38% incidence of slight prematurity. • Smoking in both groups was a confounding variable.

10. Conclusions • Pregnancies while maintained on methadone will occur with the normalization of endocrine function. • This study does not support a need to advise women to reduce dose or duration of treatment during pregnancy to reduce risks of NAS or to improve gestational age or birth weight. • Women are sometimes not aware that conceiving on methadone results in fetal dependence. • Informed consent of the risks of fetal dependence is essential for all women.

11. GETTING PREGNANT ON METHADONE? • You are being given this letter because you are on methadone and have the potential to become pregnant. We want all our female patients to understand that a baby will be dependent on methadone and subject to opiate withdrawal if it is conceived on methadone. • Conceiving on methadone often means that the baby will be on methadone throughout the pregnancy. Although there is a possibility that a woman could withdraw from methadone during pregnancy, any withdrawal attempt must be very slow and carefully monitored to assure that the baby is not experiencing distress in the womb. There is also risk of causing miscarriage or premature labor if the withdrawal is too fast. Finally, there is a risk to the mother of relapsing to drug use during a withdrawal attempt. • At the time of delivery, the baby will be assessed in the hospital for signs and symptoms of withdrawal, which is called neonatal abstinence. Most babies will have some symptoms of withdrawal from methadone no matter what the mother’s dose is. Infant withdrawal is not related to the mother’s methadone dose. However, about half of the babies of the mothers in Bi-Valley’s pregnancy program have withdrawal that is mild enough not to require treatment with medications. These babies go home with the mother, usually within the first few days. In other research studies, as many as 80% of babies require medications. If the baby does have withdrawal symptoms that are severe enough to require medications, the baby will likely be kept in the hospital for between three and six weeks to be tapered slowly off opiates. • We do, however, recognize that some women may feel that conceiving on methadone is the surest way to have a drug-free pregnancy. They may feel that methadone treatment provides the best way to remain drug free, healthy, and prepared to parent. We respect a woman’s decision to conceive on methadone for these reasons. The good news is that babies conceived on methadone and exposed during the whole pregnancy do well after the period of withdrawal. There appears to be no increased risk of withdrawal to the baby of exposure to methadone for the entire pregnancy, compared to shorter periods of methadone exposure. There seem to be no long-term complications related to methadone exposure throughout the pregnancy. Also, you can nurse your baby while on methadone, which we encourage. • In summary, we need to emphasize the decision to conceive on methadone entails a significant risk of neonatal withdrawal and the risk for up to six weeks of hospital treatment after delivery. For this reason, we cannot recommend conceiving on methadone, but we respect the woman’s right to make her own decision about this. We will, of course, help any pregnancy woman who conceives on methadone to have the best possible birth outcome. Please inform your counselor as soon as you think you are pregnant, so that our specialized care for you and your baby can begin as soon as possible. If you have any questions, please contact our medical staff for more information.   Sincerely,  Dr. John McCarthy