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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539759
First Posted: February 27, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Erika Levi, MD, MPH, University of North Carolina, Chapel Hill
  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
Intrauterine Devices Cesarean Section Device: Immediate Postplacental Placement of an IUD during cesarean delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Erika Levi, MD, MPH, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • IUD Use [ Time Frame: 6 months postpartum ]
    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 ]
  • Women's Satisfaction With IUDs [ Time Frame: 0-6 months postpartum ]

Enrollment: 112
Study Start Date: March 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539759


Locations
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: February 21, 2012
First Posted: February 27, 2012
Results First Submitted: June 16, 2015
Results First Posted: July 9, 2015
Last Update Posted: October 13, 2017
Last Verified: September 2017

Keywords provided by Erika Levi, MD, MPH, University of North Carolina, Chapel Hill:
Postpartum Contraception
Intrauterine Devices