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

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)

Study type: Interventional

Funder types: Other

Identifiers

NCT00733278

12670-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman
• Requires elective C-section
• Desires long-term contraception

Exclusion criteria

• Contraindications to copper IUD

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Copper IUD

Experimental group

Description:

Copper IUD

Treatment:

Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)