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Completed

NCT Number: NCT01439802

Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

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

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Key information

Conditions

Intrauterine Device Expulsion Behavior Personal Satisfaction

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Jacobi Medical Center, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Placement of Paragard IUD at time of Cesarean Delivery

Other names: Copper T 380A

Primary outcomes

  1. Number of Participants With Expulsion of IUD

    Time frame: 6 week postpartum

    Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Secondary outcomes

  1. Satisfaction of IUD Placement

    Time frame: 6 months postpartum

    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.

  2. Number of Participants With Expulsion of IUD

    Time frame: 6 months postpartum

    Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Official study title

Transcesarean IUD Insertion: A Prospective Cohort Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 23, 2011
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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