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:
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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 |
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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 |
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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 |
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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) |