BLIS - Breastfeeding Levonorgestrel IUD Study

NCT01990703 ↗

Phase 4 Completed 285 enrolled University of Utah Society of Family Planning · collab University of New Mexico · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-01
Primary completion: 2016-11
Completion: 2017-01

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper though the study was not powered to detect noninferiority between groups. PMID 33478494 ↗

Publications

Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	—	Other

Indications

No indication recorded.