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

Contraception Clinical Trial

Official title:

Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733278
• Other study ID #: 12670-01
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: July 16, 2014
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2014
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant woman

• Requires elective C-section

• Desires long-term contraception

Exclusion Criteria:

• Contraindications to copper IUD

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Intraoperative placement of copper IUD at time of C-section

Locations

Country	Name	City	State
United States	Los Angeles BRI	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Retention of IUD		6 weeks	Yes
Secondary	Visibility Within the Vagina of IUD Strings at All Times.		At 3 days, 2 weeks and 6 weeks postpartum	Yes