Mahmood 2011.
Methods | Randomized controlled trial. November ‐ December 2009, Islamabad, Pakistan. |
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Participants | 183 healthy, full‐term infants and their mothers anticipating spontaneous vaginal delivery at the Department of Obstetrics of Pakistan Institute of Medical Sciences, Islamabad with intention to exclusively breast feed their infants for at least 1 month. Mothers were excluded if they had multiple pregnancy, pre‐existing medical complications (diabetes, gestational diabetes, pregnancy‐induced hypertension, renal failure, heart disease, psychiatric illness, etc.), severe postpartum hemorrhage, cesarean section, severely retracted/inverted nipples, or passage of meconium during labor. Infant inclusion criteria: babies who did not need resuscitation beyond oro‐pharyngeal suction, Babies with gestation < 37 weeks, weight < 2500 g, signs of respiratory distress after birth, major congenital anomalies, floppiness or birth trauma were excluded. |
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Interventions | 1) SSC infants (n = 92) were placed on their mother’s abdomen immediately post birth, dried and then moved to their mother’s chest between her breasts and covered with a cap and a pre‐warmed sheet. SSC ended after the first feeding. 2) Infants in the control group (n = 91) were moved to the radiant warmer immediately post birth, cleaned, wrapped in pre‐warmed sheets and transferred to the postpartum unit with their mothers and breastfeeding began when the mother was ready. |
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Outcomes | Success of the first feeding (IBFAT scores 10‐12), time to initiate breastfeeding, time until effective breastfeeding (first of 3 consecutive IBFAT scores of 10‐12), maternal satisfaction with care and preference for the same post‐delivery care with subsequent pregnancies, breastfeeding exclusivity at 1‐month post birth. | |
Notes | Subgroups: Immediate SSC. Low dose (duration of first feed not stated in report). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes opened sequentially; not stated if envelopes were opaque. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition for IBS at 30 days 68/80 intervention group and 67/80 control group. Unclear why data reported for 80 in each group when number randomized was 92 and 91 in treatment and controls, respectively. |
Selective reporting (reporting bias) | Low risk | Not apparent. |
Other bias | Low risk | No significant inter‐group baseline difference was noted, except that multi‐parous mothers with no previous experience of breastfeeding were more in CC group (P = 0.04). |