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Intrauterine Device (IUD) Placement at the Time of Cesarean Section

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Kentucky.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Duramed Research
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00986089
First received: September 25, 2009
Last updated: September 28, 2009
Last verified: September 2009
History of Changes
  Purpose

To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.


Condition
Intrauterine Device Placement

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of Copper IUD Placement at the Time of Cesarean Section

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Continuation at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • satisfaction with placement at time of cesarean [ Time Frame: 4-6 months and 1 year ] [ Designated as safety issue: No ]
  • bleeding profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Groups/Cohorts
women who have an IUD placed at the time of c-section

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.

Criteria

Inclusion Criteria:

  • Desire an IUD post-partum and are willing to use the copper IUD.
  • They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.

Exclusion Criteria:

  • Post-partum hemorrhage,
  • Chorioamnionitis (or a fever >101 at the time of cesarean),
  • Women on antibiotic or immunosuppressive therapies,
  • Cervical dilation > 5 cm at the time of c-section, OR
  • Excessive intraoperative blood loss.
  • Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Kristine Lain, MD, University of Kentucky
ClinicalTrials.gov Identifier: NCT00986089     History of Changes
Other Study ID Numbers: 08-0938-F6A
Study First Received: September 25, 2009
Last Updated: September 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
post-placental
IUD
Copper IUD
 cesarean section
immediate post-partum
continuation

ClinicalTrials.gov processed this record on May 23, 2013