Nexplanon Application Post-Abortion (NAPA)

Family Planning Associates Medical Group, LTD

Status: Completed

Conditions: Contraception; Abortion, Therapeutic

Treatments: Other: Immediate Nexplanon Insertion; Other: Post-op Nexplanon Insertion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02037919

IIS#50302: Women's Health MISP

Details and patient eligibility

About

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.

Full description

Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

148 participants in 2 patient groups

Immediate Nexplanon Insertion

Experimental group

Description:

An etonogestrel rod will be placed within 15 minutes following the abortion procedure.

Treatment:

Other: Immediate Nexplanon Insertion

Post-op Nexplanon Insertion

Active Comparator group

Description:

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.

Treatment:

Other: Post-op Nexplanon Insertion