Turok 2014.

Trial name or title	BLIS ‐ Breastfeeding Levonorgestrel IUD Study
Methods	Time frame and location: January 2014 to December 2015 in Albuquerque, NM, and Salt Lake City, UT (USA) Randomized controlled trial, non‐inferiority, phase 4; open label Sample size calculation and outcome of focus: no mention
Participants	General with N: 317 pregnant women Inclusion criteria: healthy; 18 to 40 years old; pregnant; intention to breastfeed; desire for LNG‐IUD (levonorgestrel‐releasing intrauterine device) as method of contraception; delivered healthy term infant (37 weeks gestation) 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)
Interventions	Levonorgestrel‐releasing IUD Treatment: immediately after delivery of baby and placenta (within 10 minutes) Comparison: 4 to 6 weeks after delivery Timing: as above
Outcomes	Measures: breastfeeding continuation and exclusivity; lactogenesis stage 2 (first 5 days after birth) Assessments: 5 days (lactogenesis stage 2); 8 and 26 weeks (breastfeeding)
Starting date	January 2014; estimated primary completion December 2015
Contact information	Contact: Maria Masters; maria.masters@hsc.utah.edu; 801‐213‐2286 PI: David K Turok, MD; University of Utah, Department of Obstetrics and Gynecology
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