Allott 1993.
Methods | Prospective randomised controlled trial | |
Participants |
Setting: antenatal clinic of district general hospital, UK. Page 898 Duration of study: 18 months. Page 898 Inclusion criteria: “Beyond 40 weeks gestation as determined by mid‐trimester ultrasound scanning.” “Pregnancies in which no risk factors such as intra‐uterine growth restriction or hypertension had been detected”. Page 898 Exclusion criteria: “Those presenting with a closed cervix were not included in the trial as the cervix has to be potentially sweepable” Page 898 Parity: mixed. Both nulliparous and multiparous women included (% presented in Table 1 of manuscript page 899). 43/99 (43.4%) nulliparous women in membrane sweeping group versus 44/96 (45.8%) nulliparous women in control group. 56/99 (56.6%) multiparous women in membrane sweeping group versus 52/96 (54.2%) multiparous women in the control group. Bishop score: Score ≤ 6 and Score ≥ 7 recorded |
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Interventions |
Membrane stripping(n = 99): a vaginal examination was performed to assess the Bishop score. “The sweep was performed by inserting the examiners index finger as far through the internal cervical os as possible and rotating twice through 360 degrees”. Page 898 Control group (n = 96): “A vaginal examination was performed to assess the Bishop score”. Page 898 “After the initial intervention there were no further differences in management” between the groups“. “All were assessed by the same person to minimise subjective differences”. All women were given a deadline date for labour induction in the absence of a spontaneous onset. A minimum gap of 4 days was planned between the examination and the induction in all cases. Sweeping of membranes or Bishop's score performed by the principal investigator. Page 899 |
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Outcomes | Spontaneous vaginal delivery Induction of labour Caesarean section operative vaginal birth Apgar score < 6 at 5 minutes serious neonatal infection Serious neonatal outcomes Epidual in labour Maternal pyrexia?? number of women starting spontaneous labour reported for every day between day 1 to day 7 after randomisation. |
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Notes |
Funding: none declared Trial authors’ declaration of interest: Dr. D. Elbourne, Oxford perinatal epidemiology unit advised in study design. Mr. A. Smith helped in preparation of manuscript. Informed consent obtained: “all gave informed consent” Ethical approval: unclear; “after reading an explanatory document as stipulated by the district ethical committee” Email for further information sent 28 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 | “Using a computer generated list of random numbers, women were randomised to a membrane sweep or no further procedure. A sealed envelope was opened for each woman after entry into the trial”. Page 898. |
Allocation concealment (selection bias) | Unclear risk | “A sealed envelope was opened for each woman after entry into the trial” It is not reported if envelope was opaque, sequential or numbered. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants: not discussed Binding of personnel: “All were assessed by the same person (H.A.) to minimise subjective differences in evaluation”. Page 898. |
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) | Unclear risk | Insufficient information given to make informed judgement.However it is noted that caesarean section data unclear. Table 3, page 901 figures differ from written report. |
Other bias | Low risk | No other bias noted. |