Wiriyasirivaj 1996.
Methods | Randomised controlled trial | |
Participants |
Setting: Antenatal clinic, Maharaj Nakorn Chiang Mai University Hospital, Thailand. Duration of study: 4 October 1994 to 4 November 1994. Participants randomised: N = 120 Inclusion criteria: 38 weeks' gestation with, “certain dates assessed by known last menstrual period, early assessment by uterine size, or examination by ultrasound before 28weeks' gestation. Vertex presentation, ability to attend follow‐up visits. Intention to deliver at the Maharaj Nakorn Chiang Mai University hospital.” Page 767 Exclusion criteria:“previous caesarean section, known medical, surgical or obstetric complications of pregnancy that would preclude vaginal delivery.” Size‐date discrepancy during antenatal visits. Placenta praevia or low lying placenta as assessed by ultrasound.” Page 767 Parity: mixed. Both nulliparous and multiparous women included. Bishop score: initial Bishop score recorded. |
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Interventions | “gentle pelvic examinations were done in both groups to assess the status of the cervix by Bishop scoring.”Page 767“only one obstetrician performed membrane stripping and Bishop scoring in all patients” Page 768 Membrane stripping (N = 61): “Membranes were stripped by digital separation from the lower uterine segment as far as possible, using a gloved examining finger”. “Unfavourable cervices were stretched digitally as much as possible, or until membrane stripping could be accommodated” Page 767 Control group (N = 59): “gentle pelvic examination for Bishop scoring” Page 768 “Gentle pelvic examinations for Bishop scoring was continued weekly in both groups, whereas the study group also had the membranes stripped weekly until the onset of labour. If gestational age reached 42 completed weeks without spontaneous onset of labour, formal induction was scheduled with either prostaglandin vaginal suppository or intravenous oxytocin drip.” Page 768 |
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Outcomes | Intrapartum fever Oxytocin Method of delivery Spontaneous Forceps Vacuum Caesarean Postpartum fever PPH Chorioamnionitis |
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Notes |
Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: yes, “After giving informed consent, subjects were assigned to one of two groups” Ethical approval: yes, “The study was approved by the ethical committee of the Faculty of Medicine, Chiang Mai University” Email requesting further data sent 30 August 2017. Resent 20 September 2017. No reply to date. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “subjects were assigned to one of two groups according to a table of random numbers. A simple randomization scheme was prepared by a research nurse before the trial began” Page 767 |
Allocation concealment (selection bias) | Unclear risk | “the code for each patient was kept in a sealed, black opaque envelope”. Not reported if envelopes were sequential or numbered. Page 767 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not reported. 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. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. Protocol not available |
Other bias | Low risk | No evidence of other bias. Protocol not available |