Pregnancy Clinical Trial
Official title:
A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women.
The investigators have designed a single site, Phase IV open label, prospective observational clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus standard postpartum contraceptive care (control) on consistent contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.
Background: Opioid dependence in pregnancy has increased dramatically in the last decade.
Over 86% of pregnancies conceived by OD women are unintended, compared to 31-43% of
pregnancies in the general population. In evaluations of contraceptive use among sexually
active women in opioid treatment programs, 40-75% of sexually active OD women report no
contraceptive use. Even among women using contraception, 45-55% report using only condoms
without more effective, hormonal contraception. Pregnancy and the postpartum period are
unique opportunities to provide contraceptive education and services. Long-acting reversible
contraception (LARC) has been shown to more effectively prevent rapid repeat, unintended
pregnancies compared to other postpartum contraceptive options and does not incur the risk of
venous thromboembolism associated with estrogen-containing methods (i.e. pills, ring, patch).
No studies have evaluated the impact of immediate postpartum etonogestrel implant (Nexplanon)
placement on reproductive health outcomes in OD women, a population at significant risk for
rapid repeat, unintended pregnancy. In contrast to an intrauterine device (IUD), Nexplanon is
safe to insert regardless of labor and delivery circumstances, does not incur an increased
risk of postpartum expulsion and is long-acting, which makes it the ideal contraceptive for
the immediate postpartum period.
Study site:This single site study will be conducted at Magee-Womens Hospital (MWH) of the
University of Pittsburgh Medical Center.
Study Procedures: Recruitment - participants will be recruited during the third trimester of
pregnancy (≥ 28 weeks gestation) during prenatal care visits.
Immediate postpartum Nexplanon placement (IPP) - participants who choose to enroll in the IPP
Nexplanon arm will have Nexplanon placed in the immediate postpartum period (2-4 days
following delivery), prior to hospital discharge.
Standard postpartum contraceptive care (control) - participants who choose to enroll in the
control arm will receive a contraceptive method of their choice according to standard
clinical protocols. Standard clinical protocols include condoms, Depo Provera (DMPA) or
progestin-only pills initiated at any time after delivery, Nexplanon insertion at > 4 weeks
after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any
time > 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion
any time > 6 weeks after delivery.
Study Duration: 12 months
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