Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Intrauterine Device Expulsion Clinical Trial

Official title:

Transcesarean IUD Insertion: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439802
• Other study ID #: 2007-345-002
• Status: Completed
• Phase: Phase 4
• Start date: August 2008
• Est. completion date: May 2010

Study information

• Verified date: April 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Device Expulsion

Intervention

Device:
• Copper IUD placement at time Cesarean Delivery (Copper T 380A)
Placement of Paragard IUD at time of Cesarean Delivery

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore Medical Center, Weiler Division	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Expulsion of IUD	Number of participants with Expulsion of IUDs placed at time of cesarean delivery.	6 week postpartum
Secondary	Satisfaction of IUD Placement	Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD.	6 months postpartum
Secondary	Number of Participants With Expulsion of IUD	Number of participants with Expulsion of IUDs placed at time of cesarean delivery.	6 months postpartum