Expired Study
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Torrance, California 90502


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Pregnant woman - Requires elective C-section - Desires long-term contraception Exclusion Criteria: - Contraindications to copper IUD


Study is Available At:


Original ID:

12670-01


NCT ID:

NCT00733278


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Los Angeles Biomedical Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anita L Nelson, MD
Principal Investigator
Los Angeles Biomedical Research Institute

Study Dates

Start Date:November 2007
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 28, 2013
First Received Date:August 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Retention of IUD with tail strings visible at all times
Time Frame:At 3 days, 2 weeks and 6 weeks postpartum
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Successful placement of IUD
Time Frame:Immediate
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Copper IUD ( ParaGard Intrauterine Contraceptive D
Description:Intraoperative placement of copper IUD at time of C-section
Arm Name:Copper IUD
Other Name:ParaGard Intrauterine Contraceptive Device

Study Arms

Study Arm Type:Experimental
Arm Name:Copper IUD
Description:Copper IUD

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Los Angeles Biomedical Research Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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