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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037919
Other study ID # IIS#50302: Women's Health MISP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date May 2017

Study information

Verified date February 2024
Source Family Planning Associates Medical Group, LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Immediate Nexplanon Insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
Post-op Nexplanon Insertion
Place Nexplanon at post operative visit rather than at surgery

Locations

Country Name City State
United States Family Planning Associates Medical Grooup, LTD Chicago Illinois
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Family Planning Associates Medical Group, LTD Merck Sharp & Dohme LLC, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Implant Inserted Whether participants had the implant inserted as part of the study Within 4 weeks of abortion
Other Completed 6-month Phone Call Whether participants completed 6-month phone call follow-up. 6 months
Primary Intention-to-treat Analysis of Etonogestrel Implant Use Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations. 6 months
Primary Per-protocol Analysis of Etonogestrel Implant Use Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations. 6 months
Secondary Repeat Pregnancy Occurrence of a pregnancy within 6 months after second-trimester abortion. 6 months
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