A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Time
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.
The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.
Detailed Description
Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.
Investigators
Amy Bryant
Fellow
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
- •Primary Inclusion Criteria:
- •Ages 18-45 attending prenatal care
- •Greater than 34 weeks estimated gestational age
- •Desire to use the CuT380A-IUCD for contraception postpartum
- •Plan to stay in the area for at least 5 months postpartum
- •If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
- •No prior cesarean delivery
- •No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
- •No known uterine anomalies
- •No known pelvic tuberculosis
Exclusion Criteria
- •prior cesarean section
- •fever during labor and delivery
- •AIDS, not well on antiretroviral therapy
- •genital tuberculosis
- •known uterine abnormalities or genital tract cancer
- •history of ectopic pregnancy within 3 months of current pregnancy
Outcomes
Primary Outcomes
Time
Time Frame: 6 months
Estimate the time required to enroll 140 women into this study
Secondary Outcomes
- Expulsion rates(6 months)
- Satisfaction(6 months)