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. 2015 Mar 20;2015(3):CD003988. doi: 10.1002/14651858.CD003988.pub2

Gurtcheff 2011.

Methods Time frame and location: January to October 2009 in Salt Lake City, Utah (USA)
Described as non‐inferiority trial
Sample size calculation and outcomes of focus:
  • lactation failure: assuming 5% failure in both groups, n = 27 per group for 80% power and 15% non‐inferiority margin;

  • hours to lactogenesis II: assuming mean 54 ± 12, n = 34 per group for 80% power, and non‐inferiority margin of 8 additional hours

Participants General with N and source: 69 healthy peripartum women
Inclusion criteria: healthy; intended to breastfeed
Exclusion criteria: onset of lactogenesis before randomization; hemorrhage requiring transfusion; severe pregnancy‐induced hypertension; prolonged hospitalization; coagulopathy; liver disease; undiagnosed genital bleeding; other contraindication to etonogestrel implant insertion; taking inducers of hepatic enzymes
Interventions Etonogestrel implant with different insertion times
Treatment: early insertion, 1 to 3 days postpartum
Comparison: standard insertion, 4 to 8 weeks postpartum
Timing: See above
Outcomes Measures: lactation failure (assessed 3 times daily in hospital and at least daily after discharge; diagnosed by 120 hours); time to lactogenesis stage II (copious milk secretion); breastfeeding, full or any (shown in figure without actual numbers); creamatocrit for fat and energy content of milk sample from 6‐week visit
Assessments: 2 and 6 weeks, 3 and 6 months postpartum
Notes Investigator provided data for breastfeeding continuation (full or any).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers in varying blocks of 2, 4, 6
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded; considered not feasible
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Loss to follow‐up: early insertion 17% (6/35); standard insertion 18% (6/34)