Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study
Completed
Conditions studied: Postpartum, Intrauterine Devices, Copper
In brief
This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.
Key facts
- Study ID
- NCT02706340
- Run by
- University of Pennsylvania
- People needed
- 309
- Starts
- 2015-04-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-11-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Adult woman age 18 years or more
- Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
- Anticipating a delivery at the Hospital of the University of Pennsylvania
- Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
- Able and willing to give consent in English
- Willing to follow up 6 months after delivery
You may not qualify if…
- Allergy or contraindication to TCu380A
- Known cervical cancer or carcinoma in situ
- History of undiagnosed abnormal vaginal bleeding prior to pregnancy
- Unwilling to follow up in the six months following delivery will be excluded
- Additional exclusion criteria apply after delivery:
- Preterm delivery (33 weeks 6 days gestation or less at birth)
- Clinical diagnosis of chorioamnionitis or treatment for presumed chorioamnionitis
- No longer desiring immediate postplacental TCu380A placement
- Subjects aged less than 18 years
- Men are excluded by the nature of this women's health research.
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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