Hemminki 1990a.
Methods | 2 RCTs reported in the same publication. The Zelen method was used: only those participants randomised to the experimental group were told the true purpose of the trial and asked for consent. The participants in the control group were told about the study in the introduction letter for the postpartum questionnaire and they were told it was "a study on factors influencing birth". | |
Participants | Healthy nulliparous and parous women in labour at a hospital in Finland. 86 women were enrolled in Trial A. The actual number enrolled to each group was not noted but medical record data were collected for 79 women (41 in the support group and 38 in the control group). These 79 women represented 91.9% of the total sample | |
Interventions | Trial A: in 1987, the intervention was 1:1 support by midwifery students from enrolment until transfer to the postpartum ward. The midwifery students volunteered, were not specially trained in support and responsible for the other routine intrapartum care. The control group 'was cared for according to the normal routine of the midwife and by a medical student, if s(he) was on duty'. Over 70% of fathers were present |
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Outcomes | Labour length, medical interventions, complications (mother and baby), pharmacologic pain relief, method of birth, mothers' evaluations of their experiences | |
Notes | Not stated if epidural analgesia was available or if EFM was used routinely Dates of study: "spring 1987" Funding: Study supported by a grant from the Finnish Academy of Sciences. 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 mention of how the allocation sequence was produced |
Allocation concealment (selection bias) | Unclear risk | "Randomization coding was done in blocks of 6 and put into non‐transparent envelopes. The envelope was opened at the reception ward when it was decided to transfer mother to labour ward." It was not stated if the envelopes were consecutively numbered |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participant's family, and labour room staff were not blinded to group assignment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes were collected from medical records by a researcher who was not blinded to group assignment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were collected on 91.9% of the sample. A questionnaire was administered at 2‐3 days postpartum. This was completed by only 70% of the sample and thus the data were not used |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | High risk | Mothers were told the purpose of the study differentially (see methods for Trial A above) |