Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amitasrigowri S. Murthy, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01439802
First received: September 21, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Intrauterine Device Expulsion
Device: Copper IUD placement at time Cesarean Delivery (Copper T 380A)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Transcesarean IUD Insertion: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Expulsion [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    Expulsion of IUDs placed at time of cesarean delivery


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    Satisfaction of subjects who received an IUD at time of cesarean delivery will be measured with the Likert Scale.


Enrollment: 90
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Copper IUD placement at time Cesarean Delivery (Copper T 380A)
    Placement of Paragard IUD at time of Cesarean Delivery
    Other Name: Copper T 380A
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439802

Locations
United States, New York
Montefiore Medical Center, Weiler Division
Bronx, New York, United States, 10461
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Amitasrigowri Murthy, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Amitasrigowri S. Murthy, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01439802     History of Changes
Other Study ID Numbers: 2007-345-002
Study First Received: September 21, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Postpartum IUD
Cesarean Delivery
6 months postpartum
satisfaction

Additional relevant MeSH terms:
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014