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OpenTrials
Completed

NCT Number: NCT01539759

Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial

This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.

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Key information

Conditions

Intrauterine Devices Cesarean Section

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women ages 18-45
  • Pregnant and greater than or equal to 24 weeks of estimated gestational age
  • Live Pregnancy
  • States a plan to use an Intrauterine Device (IUD) postpartum for contraception
  • Plan for cesarean delivery
  • Intend to stay in the Chapel Hill area for at least 6 months after birth
  • Fluent in English or Spanish

Exclusion criteria

  • known uterine anomalies
  • allergies to any component of the IUD of their choosing
  • known or suspected carcinoma of the breast
  • known acute liver disease or liver tumor (benign or malignant)
  • known or suspected uterine or cervical neoplasia
  • active pelvic inflammatory disease
  • genital bleeding of unknown etiology
  • history of solid organ transplantation
  • positive test for gonorrhea or chlamydia during this pregnancy

Treatment and study plan

Immediate Postplacental Placement of an IUD during cesarean delivery

Device

Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

Primary outcomes

  1. IUD Use

    Time frame: 6 months postpartum

    The use of an IUD at 6 months postpartum is the primary outcome measure

Secondary outcomes

  1. IUD Expulsion

    Time frame: 0-6 months postpartum

  2. Women's Satisfaction With IUDs

    Time frame: 0-6 months postpartum

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial

Acronym: IUD@CSD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2012
Registry last updated
Oct 13, 2017

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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