This trial is active, not recruiting.

Conditions contraception, abortion, therapeutic
Treatments immediate nexplanon insertion, post-op nexplanon insertion
Sponsor University of Pittsburgh
Collaborator Merck Sharp & Dohme Corp.
Start date June 2014
End date August 2016
Trial size 150 participants
Trial identifier NCT02037919, IIS#50302: Women's Health MISP


Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
immediate nexplanon insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
(Active Comparator)
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
post-op nexplanon insertion
Place Nexplanon at post operative visit rather than at surgery

Primary Outcomes

Nexplanon use
time frame: 6 months

Secondary Outcomes

Repeat pregnancy
time frame: 6 months
Side-effects of Nexplanon use
time frame: 6 mo.
Contraceptive method satisfaction
time frame: 6 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 18 years of age and older, - an intrauterine pregnancy > 14 weeks and <23 6/7 weeks gestation and desire termination of pregnancy - desire a Nexplanon for contraception - able to give informed consent in English - no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D&E Exclusion Criteria: - unable to give informed consent - have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon. - non-surgical management of pregnancy - prior participation in this study - breast cancer or a history of breast cancer

Additional Information

Official title Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)
Principal investigator Miriam Cremer, MD, MPH
Description Women will be contacted 6 months after their abortion to ask about contraception use and side effects.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.