Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section
Information source: Los Angeles Biomedical Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Copper IUD ( ParaGard Intrauterine Contraceptive Device) (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Los Angeles Biomedical Research Institute Official(s) and/or principal investigator(s): Anita L Nelson, MD, Principal Investigator, Affiliation: Los Angeles Biomedical Research Institute
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.
Clinical Details
Official title: Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Successful Retention of IUD
Secondary outcome: Visibility Within the Vagina of IUD Strings at All Times.
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant woman
- Requires elective C-section
- Desires long-term contraception
Exclusion Criteria:
- Contraindications to copper IUD
Locations and Contacts
Los Angeles BRI, Torrance, California 90502, United States
Additional Information
Starting date: November 2007
Last updated: July 16, 2014
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