Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement
Stopped early · Not applicable
Conditions studied: Contraception
In brief
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.
Key facts
- Study ID
- NCT01598662
- Run by
- University of Louisville
- People needed
- 32
- Starts
- 2009-07-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2018-09-25
Who can join
Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
- Planned vaginal delivery
- Negative third trimester cultures for Gonorrhea and Chlamydia
- Desire to use the IUD for contraception
You may not qualify if…
- Uterine anomalies
- Uterine or cervical neoplasia
- Past or current breast cancer
- Chorioamnionitis
- Acute liver disease
- Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
- Received prenatal other than at the University of Louisville OB/GYN Clinic
- Cesarean section
Where it is running
- University of Louisville — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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