Status:
COMPLETED
Postpartum Intrauterine Device Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Contraception
Intrauterine Devices
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 T3...
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-w...
Eligibility Criteria
Inclusion
- Primary
- 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
- No known genital tract cancer
- No known allergy to copper
- No known history of ectopic pregnancy within 3 months prior to pregnancy.
- No evidence of clinical anemia as assessed by a clinician at enrollment
- Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery
- Secondary Eligibility Criteria
- Vaginal delivery within the last 48 hours
- No postpartum hemorrhage documented by the delivering clinician
- Not known to have ruptured membranes for greater than 24 hours prior to delivery
- No infection diagnosed by a clinician
- No fever of greater than 38° during labour or delivery
- Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01175161
Start Date
October 1 2010
End Date
June 1 2011
Last Update
December 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina Project Lilongwe
Lilongwe, Malawi