Postpartum Intrauterine Device Study

Not Applicable

Completed

• Conditions: Contraception; Intrauterine Devices; Pilot Study; Africa
• Interventions: Device: Copper T380A Intrauterine Device

• Registration Number: NCT01175161
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Study Start: 2010-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate postpartum IUD insertion	Copper T380A Intrauterine Device	Women assigned to have the IUD placed 10 minutes to 48 hours postpartum
6 week postpartum IUD insertion	Copper T380A Intrauterine Device	Women who receive the IUD at the traditional time frame.

Primary Outcome Measures

Name	Time	Method
Time	6 months	Estimate the time required to enroll 140 women into this study

Secondary Outcome Measures

Name	Time	Method
Expulsion rates	6 months	Estimate the expulsion rate of the CuT380A-IUCD
Satisfaction	6 months	Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.

Trial Locations

Locations (1)

University of North Carolina Project Lilongwe; 🇲🇼 Lilongwe, Malawi