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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00733278
First received: August 11, 2008
Last updated: July 16, 2014
Last verified: July 2014
  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
Contraception
Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Successful Retention of IUD [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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

Enrollment: 7
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00733278     History of Changes
Other Study ID Numbers: 12670-01
Study First Received: August 11, 2008
Results First Received: October 8, 2013
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014