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Sponsored by: |
Los Angeles Biomedical Research Institute |
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Information provided by: | Los Angeles Biomedical Research Institute |
ClinicalTrials.gov Identifier: | NCT00733278 |
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 |
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Fertility Control |
Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device) |
Phase IV |
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 |
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
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 |
Principal Investigator: | Anita L Nelson, MD | Los Angeles Biomedical Research Institute |
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 |
Postpartum contraception Copper IUD |
Infertility Contraceptive Agents Trace Elements Micronutrients Copper |
Contraceptive Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs Trace Elements |
Micronutrients Reproductive Control Agents Copper Pharmacologic Actions |