Phase 4
N=285
BLIS - Breastfeeding Levonorgestrel IUD Study
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01990703 ↗Enrolled (actual)
285
Serious AEs
0.4%
Results posted
Jun 2017
Primary outcome: Primary: Breastfeeding Continuation Rates at 8 Weeks Postpartum — 88; 86 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levonorgestrel IUD (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breastfeeding Continuation Rates at 8 Weeks Postpartum |
88; 86 | — |
| SECONDARY Time to Lactogenesis Stage 2 |
65.3; 63.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01990703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.