Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 12:25 PM
Study NCT ID:
NCT01175161
Status:
COMPLETED
Last Update Posted:
2011-12-07
First Post:
2010-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Intrauterine Device Study
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPIUD
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: