Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

NCT ID: NCT01439802

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Detailed Description

This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Conditions

Intrauterine Device Expulsion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Copper IUD placement at time Cesarean Delivery (Copper T 380A)

Placement of Paragard IUD at time of Cesarean Delivery

Intervention Type: DEVICE

Other Intervention Names

Copper T 380A

Eligibility Criteria

Inclusion Criteria

• singleton gestation
• greater than 35 weeks gestation
• speaks English or Spanish
• desires IUD for contraception
• undergoing a cesarean delivery

Exclusion Criteria

• evidence of chorioamnionitis
• history of chlamydia within this pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amitasrigowri Murthy, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center, Weiler Division

The Bronx, New York, United States

Countries

United States

Other Identifiers

2007-345-002

Identifier Type: -

Identifier Source: org_study_id