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Completed

NCT Number: NCT01175161

Postpartum Intrauterine Device Study

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.

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Key information

Conditions

Contraception Africa Intrauterine Devices Pilot Study

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Project Lilongwe

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper T380A Intrauterine Device

Device

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

Primary outcomes

  1. Time

    Time frame: 6 months

    Estimate the time required to enroll 140 women into this study

Secondary outcomes

  1. Expulsion rates

    Time frame: 6 months

    Estimate the expulsion rate of the CuT380A-IUCD

  2. Satisfaction

    Time frame: 6 months

    Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study 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

Acronym: PPIUD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2010
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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