Langer 1998.
| Methods | RCT | |
| Participants | 724 women (361 to support and 363 to control) admitted for delivery at a large social security hospital in Mexico City, who met the following criteria: singleton fetus, no previous vaginal delivery, < 6 cm cervical dilatation, and no indications for an elective caesarean delivery | |
| Interventions | Support group: continuous support from 1 of 10 women who had received doula training (6 were retired nurses), throughout labour, birth, and the immediate postpartum period. Support included: emotional support, information, physical comfort measures, social communication, ensuring immediate contact between mother and baby after birth, and offering advice about breastfeeding during a single brief session postnatally. Control group: women received "routine care" |
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| Outcomes | The main outcomes were exclusive and full breastfeeding at 1 month postpartum. Other outcomes included labour length, epidural anaesthesia, forceps birth, caesarean birth, meconium staining, and Apgar scores, as well as mothers' perceived control during childbirth, anxiety, pain, satisfaction, and self‐esteem | |
| Notes | Partners and family members were not permitted. Epidural analgesia was available but it was not stated if EFM was used routinely Dates of study: not clear, received 9 July 1997 Funding: Wellstart International provided financial and technical support. Conflicts of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer generated random number list". "The treatment sequence was kept at a central level." |
| Allocation concealment (selection bias) | Unclear risk | "Opaque envelopes with the assignment were locked in a cabinet to which only a social worker exclusively in charge of randomisation and the principal investigator had access. An envelope with a paper inside showing to which group each woman was assigned was opened by the social worker immediately after recruitment in the labour and delivery unit". Not stated if envelopes were sequentially numbered |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data were collected by 2 "blinded social workers" who reviewed clinical records, but records were written by staff aware of group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data and in‐hospital interview data were collected for 100% of the sample. A in‐home interview was completed at 1 month postpartum for 92.2% of the sample |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |