Postpartum Intrauterine Device Study (PPIUD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amy Bryant, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01175161
First received: August 2, 2010
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Contraception
Intrauterine Devices
Pilot Study
Africa
Device: Copper T380A Intrauterine Device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Estimate the time required to enroll 140 women into this study


Secondary Outcome Measures:
  • Expulsion rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Estimate the expulsion rate of the CuT380A-IUCD

  • Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.


Enrollment: 115
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate postpartum IUD insertion
Women assigned to have the IUD placed 10 minutes to 48 hours postpartum
Device: Copper T380A Intrauterine Device
the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
Experimental: 6 week postpartum IUD insertion
Women who receive the IUD at the traditional time frame.
Device: Copper T380A Intrauterine Device
the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175161

Locations
Malawi
University of North Carolina Project Lilongwe
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Amy G Bryant, MD University of North Carolina, Chapel Hill
Study Director: Gretchen S Stuart, MD, MPHTM University of Carolina Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy Bryant, Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01175161     History of Changes
Other Study ID Numbers: CID-0925
Study First Received: August 2, 2010
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Postpartum Contraception
Intrauterine device
feasibility
IUD
Immediate postpartum IUD

Additional relevant MeSH terms:
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014