Ignite Creation Date:
2024-05-06 @ 8:01 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02657148
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2015-09-21
Brief Title:
Immediate Postpartum Nexplanon Placement in Opioid Dependent Women
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ie 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 siteThis 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
Study siteThis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIS53505 | OTHER_GRANT | Merck Womens Health MISP-RC | None |