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Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section

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ClinicalTrials.gov Identifier: NCT00733278
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Copper IUD
Copper IUD
Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Intraoperative placement of copper IUD at time of C-section
Other Name: ParaGard Intrauterine Contraceptive Device



Primary Outcome Measures :
  1. Successful Retention of IUD [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Visibility Within the Vagina of IUD Strings at All Times. [ Time Frame: At 3 days, 2 weeks and 6 weeks postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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): NCT00733278


Locations
United States, California
Los Angeles BRI
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

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00733278     History of Changes
Other Study ID Numbers: 12670-01
First Posted: August 13, 2008    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014
Last Verified: July 2014

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

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