Buprenorphine + naloxone in the treatment of opioid dependence during pregnancy-initial patient care and outcome data.

Research has indicated that the buprenorphine-mono product yields maternal outcomes similar to methadone and a less severe neonatal abstinence syndrome. However, maternal and neonatal outcomes following buprenorphine + naloxone exposure during pregnancy have not been documented. Retrospective chart review identified 10 opioid-dependent pregnant women treated with the buprenorphine + naloxone film product between January, 2010-June, 2011. Seven maternal outcome measures - weight gain, fetal presentation at delivery, Cesarean delivery, analgesia during delivery, urine drug screening results at delivery, number of days of maternal hospital stay, and began breastfeeding following delivery-and eleven neonatal outcome measures-gestational age at delivery, 1- and 5-minute Apgar scores, head circumference, length, and weight at birth, treated for neonatal abstinence syndrome (NAS), total amount of morphine sulfate needed to treat NAS, length of hospital stay for NAS treatment, and length of hospital stay-were extracted from medical records. Maternal findings were unremarkable, and comparable with what might be found following treatment with the buprenorphine-mono product. Neonates were full-term with normal birth parameters. Four neonates were treated for NAS, and number of days treated for NAS and number of hospital days were in line with values reported for the buprenorphine-mono product. Findings suggest no obvious significant adverse maternal or neonatal outcomes related to the use of buprenorphine + naloxone for the treatment of opioid dependence during pregnancy. These initial findings underscore the need for future research to systematically examine the relative safety and effectiveness of buprenorphine + naloxone for mother, fetus, and child.

Debelak K ，Morrone WR ，O'Grady KE ，Jones HE ... -  《-》

Buprenorphine and naloxone compared with methadone treatment in pregnancy.

Wiegand SL ，Stringer EM ，Stuebe AM ，Jones H ，Seashore C ，Thorp J ... -  《-》

Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population.

To describe the effect of in utero exposure to the buprenorphine+naloxone combination product in a rural and remote population. A district hospital that services rural and remote, fly-in communities in Northwestern Ontario, Canada. A retrospective cohort study was conducted of 855 mother infant dyads between 1 July 2013 and 30 June 2015. Cases included all women who had exposure to buprenorphine+naloxone during pregnancy (n=62). 2 control groups were identified; the first included women with no opioid exposure in pregnancy (n=618) and the second included women with opioid exposure other than buprenorphine+naloxone (n=159). Women were excluded if they had multiple pregnancy or if they were part of a methadone programme (n=16). The majority of women came from Indigenous communities. The primary outcomes were birth weight, preterm delivery, congenital anomalies and stillbirth. Secondary neonatal outcomes included gestational age at delivery, Apgar scores at 1 and 5 min, NAS Score >7 and treatment for neonatal abstinence syndrome (NAS). Secondary maternal outcomes included the number of caesarean sections, postpartum haemorrhages, out of hospital deliveries and transfer of care to tertiary centres. No difference was found in the primary outcomes or in the Apgar score and caesarean section rate between in utero buprenorphine+naloxone exposure versus no opioid exposure in pregnancy. Compared to women taking other opioids, women taking buprenorphine+naloxone had higher birthweight babies (p=0.001) and less exposure to marijuana (p<0.001) during pregnancy. Retrospective data suggest that there likely is no harm from taking buprenorphine+naloxone opioid agonist treatment in pregnancy. Larger, prospective studies are needed to further assess safety.

Jumah NA ，Edwards C ，Balfour-Boehm J ，Loewen K ，Dooley J ，Gerber Finn L ，Kelly L ... -  《BMJ Open》

Design considerations for point-of-care clinical trials comparing methadone and buprenorphine treatment for opioid dependence in pregnancy and for neonatal abstinence syndrome.

Winhusen T ，Wilder C ，Wexelblatt SL ，Theobald J ，Hall ES ，Lewis D ，Van Hook J ，Marcotte M ... -  《-》

Comparative Safety of In Utero Exposure to Buprenorphine Combined With Naloxone vs Buprenorphine Alone.

Straub L ，Bateman BT ，Hernández-Díaz S ，Zhu Y ，Suarez EA ，Vine SM ，Jones HE ，Connery HS ，Davis JM ，Gray KJ ，Lester B ，Terplan M ，Zakoul H ，Mogun H ，Huybrechts KF ... -  《-》