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Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status and phase

Completed
Phase 4

Conditions

Intrauterine Device Expulsion

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01439802
2007-345-002

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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