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

This study has been withdrawn prior to enrollment.
(Principal Investigator left the University of Kentucky before enrollment could begin.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986089
First Posted: September 29, 2009
Last Update Posted: December 22, 2016
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:
Duramed Research
Information provided by (Responsible Party):
University of Kentucky
  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:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Continuation at one year [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • satisfaction with placement at time of cesarean [ Time Frame: 4-6 months and 1 year ]
  • bleeding profile [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
women who have an IUD placed at the time of c-section

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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