BLIS - Breastfeeding Levonorgestrel IUD Study

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborators: Society of Family Planning; University of New Mexico
• Treatments: Levonorgestrel

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).