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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

Page last updated: August 23, 2015

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