Ramya 2015.
Methods | Randomised controlled trial | |
Participants |
Setting:“antenatal outpatient department of Mahatma Gandhi Medical College and Research Institute”, India (Page 1). Duration of study: January 2011 to June 2012 Participants randomised: N = 150 Inclusion criteria: “women with one previous caesarean section with non‐recurrent indications, singleton pregnancy and cephalic presentation, gestational age of 39 weeks, intact membrane and candidates willing for VBAC.” (Page 1). Exclusion criteria: “multiple gestations, malpresentations, placenta praevia, abruptioplacentae, suspected cephalo‐pelvic disproportion, gestational diabetes, chronic or gestational hypertension, pre eclampsia, gestational age less than 39 weeks, H/O premature ruptures of membranes, vasa praevia, congenital anomalies, any previous abortions, More than one transverse lower segment caesarean scar, Previous classical caesarean scar, any other uterine surgeries related to gynaecology.” (Page 1). Parity: multiparous women were included with history of a previous caesarean section (Table 1 page 2). Bishop score: "pre swiping Bishop score recorded" (Table 1 page 2). |
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Interventions |
Membrane stripping (N = 75): “During vaginal examination, if cervix admitted one finger, the foetal membranes were separated from the cervix and the lower uterine segment as far as possible by sweeping a finger through 360 degrees. When the cervix was closed attempts to stretch the cervix open or cervical massage was performed. Sweeping was done at 39 and 40 weeks.” (Page 1). Control group (N = 75): “gentle vaginal examination was done once at 39 weeks for Bishop scoring and no further examination was done till the onset of labour (Page 2). All the cases were monitored by daily Non Stress Test, amniotic fluid index was measured once in every three days till onset of labour or 41 weeks. Any condition requiring immediate delivery was excluded from the study and was managed according to the institutional protocol (Page 2). |
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Outcomes | Spontaneous onset of labour Vaginal birth after caesarean section Caesarean section Oxytocin augmentation Instrumental vaginal delivery |
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Notes | 23/75 in control group and 21/75 in Membrane sweeping group had caesarean section on maternal request. Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: yes, “informed written consent”. Ethical approval: yes,“Ethical committee clearance”. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Generation not reported “were randomly assigned” page 1 (abstract). |
Allocation concealment (selection bias) | Low risk | “reassigned into two groups by the sequential opening of numbered sealed opaque envelopes indicating a “sweep” or “No Sweep”, page 1 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not reported. Personnel: not reported. Unlikely that clinicians were blinded. |
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 noted. |
Other bias | Low risk | No evidence of other bias. |