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:
University of North Carolina, Chapel Hill
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 21, 2012 | ||||||||
| Last Updated Date | April 3, 2013 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01539759 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial | ||||||||
| Official Title ICMJE | Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial | ||||||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 112 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01539759 | ||||||||
| Other Study ID Numbers ICMJE | 11-2477 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Erika Levi, MD, MPH, University of North Carolina, Chapel Hill | ||||||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||||||
| Collaborators ICMJE | Society of Family Planning | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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