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

NCT ID: NCT00733278

Last Updated: 2014-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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

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Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Copper IUD

Copper IUD

Group Type EXPERIMENTAL

Copper IUD ( ParaGard Intrauterine Contraceptive Device)

Intervention Type DEVICE

Intraoperative placement of copper IUD at time of C-section

Interventions

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Copper IUD ( ParaGard Intrauterine Contraceptive Device)

Intraoperative placement of copper IUD at time of C-section

Intervention Type DEVICE

Other Intervention Names

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ParaGard Intrauterine Contraceptive Device

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications to copper IUD
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anita L Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Locations

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Los Angeles BRI

Torrance, California, United States

Site Status

Countries

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United States

Other Identifiers

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12670-01

Identifier Type: -

Identifier Source: org_study_id

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