Armbrust 2016.
Methods | Randomized controlled trial. | |
Participants | 205 pregnant women > 37 weeks' gestation delivering at Charite University Hospital, Berlin, Germany eligible for a primary planned cesarean section under epidural anesthesia; no bleeding disorders, no fetal anomalies, no severe maternal morbidity. | |
Interventions | 1) SSC group N = 102 Charite cesarean section birth (CCB) – the surgical drape was lowered, the infant was “walked” out of the uterus by the obstetrician, the father given the option to cut the umbilical cord and the naked infant was examined briefly for well‐being and placed on the mother’s bare breast, covered by a warm blanket and allowed to remain on the mother’s breast for the remainder of the surgical procedure and monitored constantly by the midwife. The baby remained on the mother’s breast for 1 hour or more. Babies received the intervention only if they had an Apgar > 8. 2) Control group N = 103 standard elective cesarean section – baby was taken immediately to a neonatologist or midwife for an assessment; we have had confirmation that the control group did not receive immediate SSC. |
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Outcomes | The primary outcomes were satisfaction with the birth experience, breastfeeding rates and breastfeeding problems. Secondary outcomes were time of operation, maternal blood loss, SpO², BP, length of hospitalization, infant Apgar scores and pH values. | |
Notes | Subgroups: Immediate SSC; high dose. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomization. |
Allocation concealment (selection bias) | Unclear risk | Closed envelope – authors do not state whether the envelopes were opaque or sequentially numbered. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Staff and women blind until day of surgery. Not possible to blind intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear; statistician blinded, but no mention of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 fathers in the intervention group and 12 in the control group did not return the questionnaire. 2 infants in each group were unable to complete the intervention due to requiring care of a neonatologist. |
Selective reporting (reporting bias) | Unclear risk | Apgar scores stated only as ‘not statistically different’ between groups; author has confirmed that the intervention was not delivered unless the baby had an Apgar > 8. The published trial report states that 2 cases in each arm did not receive the intervention because the baby needed care of a neonatologist; but at the same time the report states that SSC was achieved in 72% of cases, which would mean more than 2 babies in the intervention did not receive SSC. |
Other bias | Unclear risk | Women in the CCB group had higher education. |