Salamalekis 2000.
Methods | Randomised controlled trial. | |
Participants |
Setting: University of Athens “Areteion” hospital, Athens, Greece. Duration of study: not reported. Participants randomised: N = 104 Inclusion criteria: nulliparous, gestational age between 40 ‐41 weeks (281 to 287 days), singleton pregnancy and cephalic presentation. Bishop score ≤ 5. Uneventful pregnancy with gestational age determined clinically and by ultrasound during their 1st trimester (Page 241). Exclusion criteria: no maternal complications (hypertension, diabetes) or the fetus (congenital anomalies, growth retardation) (Page 241). Parity: primiparous women only included. Bishop score: initial Bishop score (Table I, Page 241) and Bishop score on admission to labour ward (Table II, page 242) recorded. |
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Interventions |
Membrane stripping (N = 34): “Sweeping of the membrane with a bishop score ≤ 5. During the procedure the examiners fingers were inserted as far as possible through the internal os, separating the membranes from the lower uterine segment and rotating 360◦.” (Page 241). Oxytocin uterine stimulation (n = 35): “Uterine stimulation with very low doses of Oxytocin for 6 hours. A diluted oxytocin infusion of 10 IU per 1000 mL of Ringers lactate solution was prepared and I.V. infusing was initiated with 0.5mU/min which was doubled hourly, reaching a maximum of 4mU/min. All these patients had continuous cardiotocographic monitoring throughout the 6 hour infusing period.” (Page 241). Control group (N = 35): “Gentle vaginal examination.” (Page 241). All patients were “followed up for 4 days after the vaginal examination or sweeping of the membranes and were filed in a fetal movement chart.”. “When signs of labour were noted they were transferred to the labour ward” (Page 241). |
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Outcomes | Spontaneous onset of labour Chorioamnionitis Caesarean section Induction of labour |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: not stated Ethical approval: not stated Email sent 28/08/17, 2 November 2017 requesting further information. No reply to date |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Type of randomisation not reported. ”our randomly selected study” page 241 |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not reported. Personnel: not reported. It was not possible to blind the clinician who gave the intervention. It is unclear if the same clinician was there at the birth or made the decisions that might affect outcomes. |
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 to make informed decision. Trial protocol not available. |
Other bias | Low risk | No evidence of other bias. |