Postpartum Intrauterine Device Study

NCT01175161 | Completed DMC

• 1 other identifier: CID-0925
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception; Intrauterine Devices; Pilot Study; Africa

Keywords

Postpartum Contraception; Intrauterine device; feasibility; IUD; Immediate postpartum IUD

Outcome Measures

Primary Outcomes (1)

• Time

  Estimate the time required to enroll 140 women into this study

  6 months

Secondary Outcomes (2)

• Expulsion rates

  6 months

• Satisfaction

  6 months

Study Arms (2)

Immediate postpartum IUD insertion

EXPERIMENTAL

Women assigned to have the IUD placed 10 minutes to 48 hours postpartum

Device: Copper T380A Intrauterine Device

6 week postpartum IUD insertion

EXPERIMENTAL

Women who receive the IUD at the traditional time frame.

Device: Copper T380A Intrauterine Device

Interventions

Copper T380A Intrauterine Device DEVICE

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

6 week postpartum IUD insertion; Immediate postpartum IUD insertion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Project Lilongwe

Lilongwe, Malawi

Location

Related Publications (1)

• 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.

  PMID: 24069753 DERIVED

Study Officials

• Amy G Bryant, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Gretchen S Stuart, MD, MPHTM

  University of Carolina Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

MA (1)