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Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial (IUD@CSD)

This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Erika Levi, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01539759
First received: February 21, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Intrauterine Devices
Cesarean Section
 Device: Immediate Postplacental Placement of an IUD during cesarean delivery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • IUD use [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    The use of an IUD at 6 months postpartum is the primary outcome measure


Secondary Outcome Measures:
  • IUD Expulsion [ Time Frame: 0-6 months postpartum ] [ Designated as safety issue: No ]
  • Women's satisfaction with IUDs [ Time Frame: 0-6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Interval IUD Placement
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
Experimental: Immediate Postplacental IUD placement
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
 Device: Immediate Postplacental Placement of an IUD during cesarean delivery
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539759

Contacts
Contact: Erika Levi, MD, MPH 919-843-8066 Erika_Levi@med.unc.edu
Contact: Gretchen Stuart, MD 919-966-7783 gstuart@med.unc.edu

Locations
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Erika Levi, MD     919-843-8066     Erika_Levi@med.unc.edu    
Contact: Gretchen Stuart, MD     919-966-7783     gstuart@med.unc.edu    
Principal Investigator: Erika Levi, MD, MPH            
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Society of Family Planning
Investigators
Principal Investigator: Erika Levi, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Erika Levi, MD, MPH, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01539759     History of Changes
Other Study ID Numbers: 11-2477
Study First Received: February 21, 2012
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Postpartum Contraception
Intrauterine Devices

ClinicalTrials.gov processed this record on June 18, 2013