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Completed

NCT Number: NCT00733278

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

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.

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Los Angeles BRI

Torrance, California, 90502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to copper IUD

Treatment and study plan

Copper IUD ( ParaGard Intrauterine Contraceptive Device)

Device

Intraoperative placement of copper IUD at time of C-section

Other names: ParaGard Intrauterine Contraceptive Device

Primary outcomes

  1. Successful Retention of IUD

    Time frame: 6 weeks

Secondary outcomes

  1. Visibility Within the Vagina of IUD Strings at All Times.

    Time frame: At 3 days, 2 weeks and 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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