El‐Torkey 1992.
Methods | Randomised controlled trial | |
Participants |
Setting: Antenatal clinic, district maternity hospital, UK Duration of study: June 1990 to March 1991 Inclusion criteria: pregnant women between 41 and 42 weeks' gestation. "women who opted for induction of labour were randomly allocated to undergo sweeping of the membranes or to act as controls". Deadline date for labour induction given after randomisation. Page 456 Exclusion criteria: none stated Parity: mixed. Both nulliparous and multiparous women included. Bishop score: cervix > 4 cm at first exam |
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Interventions |
Membrane stripping (n = 33): “As much of the membranes as possible was separated from the lower segment” “If cervix would not admit a finger it was massaged vigorously to encourage prostaglandin release”. “Sweeping of the membranes was performed by one of the authors (M.E‐T.).” “After allocation the subjects were given a date for formal induction of labour”Page 456 Control group (n = 32): no vaginal examination. Page 456 |
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Outcomes | Spontaneous onset of labour: Epidural Mode of birth Caesarean section Forceps Spontaneous Neonatal outcomes Apgar < 6 at 5 minutes Serious neonatal infection Neonatal perinatal death |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: no, only women in sweeping group were "informed of the purpose of the trial". page 456 Ethical approval: no,”formal ethical approval of the study was not sought” Unable to contact either author. Unable to locate current place of work or email address. Hospital trial was set in now closed. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by “random permuted blocks”. Page 456. |
Allocation concealment (selection bias) | Unclear risk | The randomisation codes were placed in opaque sealed envelopes which “were kept in the antenatal clinic”. Page 456. However not noted if envelopes were sequential or sealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: "Those who were randomized to sweeping were informed of the purpose of the trial and the procedure". "The women randomized to the control group were not aware that they were taking part". Page 456. Personnel: not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias. “Because of this marked difference in the proportions of subjects achieving spontaneous labour the trial was stopped before 110 women were recruited. The decision to stop the trial was made by the authors themselves, the decision being based on the statistical stopping rule for randomized trials (Pocock,1983)” |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias noted. |
Other bias | Low risk | No evidence of other bias noted. |