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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate postpartum IUD insertion | Experimental | Women assigned to have the IUD placed 10 minutes to 48 hours postpartum |
|
| 6 week postpartum IUD insertion | Experimental | Women who receive the IUD at the traditional time frame. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper T380A Intrauterine Device | Device | the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time | Estimate the time required to enroll 140 women into this study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion rates | Estimate the expulsion rate of the CuT380A-IUCD | 6 months |
| Satisfaction | Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum. |
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Inclusion Criteria:
Primary Inclusion Criteria:
Secondary Eligibility Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy G Bryant, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Gretchen S Stuart, MD, MPHTM | University of Carolina Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Project Lilongwe | Lilongwe | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24069753 | Derived | Bryant AG, Kamanga G, Stuart GS, Haddad LB, Meguid T, Mhango C. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial. Afr J Reprod Health. 2013 Jun;17(2):72-9. |
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| 6 months |