Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439802
Other study ID # 2007-345-002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00621543 - Insertion of an Intrauterine Device (IUD) After Medical Abortion N/A