Postpartum Intrauterine Device Study

Contraception Clinical Trial

— PPIUD  

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 Details — Status: Completed

Administrative data

• NCT number: NCT01175161
• Other study ID #: CID-0925
• Status: Completed
• Phase: N/A
• First received: August 2, 2010
• Last updated: December 6, 2011
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Africa
• Contraception
• Intrauterine Devices
• Pilot Study

Intervention

Device:
• Copper T380A Intrauterine Device
the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.

Locations

Country	Name	City	State
Malawi	University of North Carolina Project Lilongwe	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	Estimate the time required to enroll 140 women into this study	6 months	No
Secondary	Expulsion rates	Estimate the expulsion rate of the CuT380A-IUCD	6 months	No
Secondary	Satisfaction	Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.	6 months	No