Stuart 2014.

Methods	Time frame and location: March 2012 to June 2013; Chapel Hill, NC (USA) RCT, phase 4 Sample size calculation and outcome of focus: no information. Planned to enroll 190; randomized 35. Study stopped early; expulsion rate met a priori stopping rules.
Participants	General with N and source: 35 women, 18 to 45 years old; Women's Hospital of North Carolina Inclusion criteria (for antepartum enrollment): Pregnant and ≥ 24 weeks of estimated gestational age; intent to breastfeed for at least 6 months; plan to use LNG‐IUS postpartum; anticipation of vaginal delivery; HIV negative; intention to stay in Chapel Hill area for at least 6 months after birth; no medical or personal conditions that in the judgment of study staff preclude participation; no allergies to any component of LNG‐IUS; no known uterine anomalies; fluent in English No history of ectopic pregnancy, carcinoma of the breast, acute liver disease or liver tumor (benign or malignant); uterine or cervical neoplasia or unresolved abnormal pap smear; active pelvic inflammatory disease; hypersensitivity to component of LNG‐IUS; genital bleeding of unknown etiology; solid organ transplantation Additional eligibility criteria for trial entry (assessed postpartum): No endometritis or chorioamnionitis; membranes ruptured < 24 hours before delivery; no fever ≥ 38°C during intrapartum or postpartum period; did not receive medication other than pitocin or misoprostol to control postpartum bleeding; did not have blood loss > 750 mL intrapartum, blood transfusion for postpartum hemorrhage, third or fourth degree laceration at delivery; infant > 35 weeks gestation as determined by physical exam; weight at least 2727 grams; singleton birth; not in intensive care nursery; not diagnosed with condition that precludes long‐term feeding Exclusion criteria: no other mention
Interventions	Levonorgestrel‐releasing IUS (20 μg) with different insertion times Treatment: inserted within 48 hours of delivery Comparison: inserted 4 to 8 weeks after delivery
Outcomes	Measures: any breastfeeding Assessments: 6 months
Notes	Information from published conference abstract, ClinicalTrials.gov listing, and communication with investigator Full report to be submitted for publication by mid‐September, according to investigator.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	1:1 allocation Computer generated by someone not involved with study activities, according to communication with investigator
Allocation concealment (selection bias)	Low risk	Sequentially numbered opaque envelopes, according to communication with investigator
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label
Incomplete outcome data (attrition bias) All outcomes	Low risk	Six‐month analysis for LNG‐IUS continuation included all women randomized.