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Postpartum Intrauterine Device Study — PPIUD  

Contraception Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01175161
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date October 2010
Completion date June 2011
View Details
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