- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01175161
Postpartum Intrauterine Device Study (PPIUD)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lilongwe, Malawi
- University of North Carolina Project Lilongwe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate postpartum IUD insertion
Women assigned to have the IUD placed 10 minutes to 48 hours postpartum
|
the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
|
Experimental: 6 week postpartum IUD insertion
Women who receive the IUD at the traditional time frame.
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the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time
Time Frame: 6 months
|
Estimate the time required to enroll 140 women into this study
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expulsion rates
Time Frame: 6 months
|
Estimate the expulsion rate of the CuT380A-IUCD
|
6 months
|
Satisfaction
Time Frame: 6 months
|
Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amy G Bryant, MD, University of North Carolina, Chapel Hill
- Study Director: Gretchen S Stuart, MD, MPHTM, University of Carolina Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CID-0925
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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