NCT00733278

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	Copper IUD ( ParaGard Intrauterine Contraceptive Device)	Intraoperative placement of copper IUD at time of C-section

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-13
• Last updated: 2014-08-11
• Results posted: 2014-08-11

Locations

1 site across 1 country: United States