BLIS - Breastfeeding Levonorgestrel IUD Study
Completed · Phase 4
Conditions studied: Contraception
In brief
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Key facts
- Study ID
- NCT01990703
- Run by
- University of Utah
- People needed
- 285
- Starts
- 2014-01-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2017-06-14
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Healthy, 18-40 year old pregnant women
- Intend to breastfeed
- Desire the LNG IUD as their method of contraception
- Agree to be randomized to early versus standard postpartum insertion
- Have delivered a healthy term infant (37 weeks gestation)
- Willing to complete all study related procedures, visits and questionnaires
You may not qualify if…
- Chorioamnionitis
- Obstetric complications including transfusion
- Severe pregnancy induced hypertension
- Prolonged hospitalization
- Coagulopathy
- Liver disease
- Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Where it is running
- University of New Mexico — Albuquerque, New Mexico, United States
- University of Utah Health Sciences Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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