Transcesarean IUD Insertion: A Prospective Cohort Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Number of Participants With Expulsion of IUD
Study Overview
Brief Summary
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Satisfaction of IUD Placement(6 months postpartum)
- Number of Participants With Expulsion of IUD(6 months postpartum)