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Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section
This study is ongoing, but not recruiting participants.
First Received: August 11, 2008   Last Updated: August 12, 2008   History of Changes
Sponsored by: Los Angeles Biomedical Research Institute
Information provided by: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00733278
  Purpose

This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.


Condition Intervention Phase
Fertility Control
Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Phase IV

MedlinePlus related topics: Birth Control Cesarean Section
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-Section: A Pilot Study

Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Successful placement of IUD [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention of IUD with tail strings visible at all times [ Time Frame: At 3 days, 2 weeks and 6 weeks postpartum ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Intraoperative placement of copper IUD at time of C-section

Detailed Description:

Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant woman
  • Requires elective C-section
  • Desires long-term contraception

Exclusion Criteria:

  • Contraindications to copper IUD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733278

Locations
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Anita L Nelson, MD Los Angeles Biomedical Research Institute
  More Information

No publications provided

Responsible Party: Los Angeles Biomedical Research Institute ( Anita L. Nelson, MD/PI )
Study ID Numbers: 12670-01
Study First Received: August 11, 2008
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00733278     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Los Angeles Biomedical Research Institute:
Postpartum contraception
Copper IUD

Study placed in the following topic categories:
Infertility
Contraceptive Agents
Trace Elements
Micronutrients
Copper

Additional relevant MeSH terms:
Contraceptive Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Trace Elements
Micronutrients
Reproductive Control Agents
Copper
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009