McGrath 2008.
| Methods | RCT. Enrollment occurred at childbirth education classes and randomisation occurred when the woman arrived at hospital in labour | |
| Participants | 420 nulliparous middle and upper class women (224 on doula group and 196 in control group) were enrolled in the third trimester of an uncomplicated pregnancy in Cleveland, Ohio. All women expected to be accompanied during labour by their male partner | |
| Interventions | Experimental group: a doula met the couple at the hospital as soon as possible after random assignment (typically within an hour of their arrival at the hospital) and remained with them throughout labour and delivery. The central component of doula support was the doula’s continuous bedside presence during labour and delivery, although her specific activities were individualised to the needs of the labouring woman. Doula support included close physical proximity, touch, and eye contact with the labouring woman, and teaching, reassurance, and encouragement of the woman and her male partner. All doulas completed training requirements that were equivalent to the DONA international doula certification. Control group: routine obstetric and nursing care which included the presence of a male partner or other support person |
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| Outcomes | Caesarean delivery, epidural anaesthesia, oxytocin use, labour length, mode of delivery, fever during labour, satisfaction at 6 weeks postpartum | |
| Notes | Epidural analgesia was available and EFM was used routinely. The author has been contacted for data split by study group and questionnaire data for the control group Dates of study: enrolment from October 1988 through October 1992. Funding: supported in full by Grant HD 16915 awarded by the National Institute of Child Health and Human Development, Bethesda, Maryland, USA. Conflicts of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details stated |
| Allocation concealment (selection bias) | Low risk | "When the research co‐ordinator was informed that an enrolled woman had arrived at the hospital in early active labour, she opened the next sequentially numbered opaque envelope to determine random assignment to the doula or control group". The research co‐ordinator was off‐site and called by the staff or the study participant |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participants' family members, and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Research assistants had access to the medical records, including information about procedures and interventions. Unclear if this includes group assignment. Questionnaires were completed by the participant and her partner, before hospital discharge |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were collected on 100% of the sample. The in‐hospital and 6‐week questionnaires were completed by 87.9% and 87.5% of the doula group. No information was provided for the control group |
| Selective reporting (reporting bias) | Low risk | The primary outcomes of caesarean birth and epidural anaesthesia were reported for each study group. Other labour and delivery outcomes were reported for the full sample only (not split by group). The in‐hospital and 6‐week questionnaire data were only reported for the doula group. The author has been contacted for these missing details |
| Other bias | Low risk | No other sources of bias noted |