Hamdan 2009.
Methods | Randomised controlled trial | |
Participants |
Setting: Outpatient clinic, University hospital, Kuala Lumpur, Malaysia. Duration of study: 3.5 year period. 2002 to 2005 Inclusion criteria: “Women with one transverse lower segment cesarean scar, a singleton pregnancy, cephalic presentation, intact membranes, and gestational age more than 36 weeks who were agreeable to VBAC and passed specialist assessment for VBAC”. Page 746 Exclusion criteria: “obstetric contraindications to VBAC (e.g. placenta previa, suspected macrosomia, suspected cephalopelvic disproportion, abnormal fetal lie, and obstructive pelvic masses).” Page 746 Parity: only multiparous women included. Bishop score: Bishop score at each session recorded (session 1 to 5). |
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Interventions |
Membrane stripping (N = 108): “Immediately after randomization, women assigned to “sweep” had their cervix stretched and membranes stripped from the lower uterine segment in the manner as previously described.” Page 746 Control group (N = 105): “Women assigned to “no sweep” had a gentle vaginal examination for their Bishop score. Page 746 “Weekly follow‐up sessions based at the antenatal clinic with the investigators were arranged to repeat membrane sweeping or vaginal examination until delivery. The Bishop score was recorded at each session In our center, induction of labor for prolonged pregnancy is typically offered at 41 weeks of gestation.19 Induction of labor for diabetes that required drug treatment is offered at 38 weeks and for gestational diabetes adequately controlled by diet, induction of labor is offered at 40 weeks.20 Upon prelabor rupture of membranes, women were offered either immediate uterine stimulation, typically with oxytocin, or expectant inpatient management for up to 24 hours.21 All women with a previous cesarean delivery who were offered formal induction of labor were counselled about a higher risk of scar rupture and of unplanned cesarean delivery and the option of a planned repeat cesarean delivery was given.” Page 746 |
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Outcomes | Spontaneous onset of labour Induction of labour Caesarean section Spontaneous vaginal delivery Augmentation of labour Instrumental delivery Caesarean delivery PPH Epidural analgesia Umbilical cord artery PH < 7.1 Apgar score 6 or less at 5 minutes |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: “All participants provided written informed consent.” Ethical approval: ethical approval for the trial was obtained from the Medical Ethics Committee of the University of Malaya Medical Center, page 746 Emailed 30 August 2017 requesting further information sent.Resent 20 September 2027. No reply to date. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “prepared by an author (M.H.) in blocks of 50 using a computer‐generated randomization sequence (available online at http://www.random.org/).” Page 746 |
Allocation concealment (selection bias) | Low risk | “sequential opening of numbered sealed opaque envelopes indicating “Sweep” or “No Sweep.” Only investigators aware of allocation. Page 746 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: “Blinding of participants and delivery providers was effected by a policy of not revealing allocated treatment to them unless requested for an important clinical need. There was no request to unblind during the trial. Page 746 Personnel: Only investigators aware of allocation. However it appears investigators preformed membrane sweep. All participants received standard management by delivery providers.” Page 746 |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Collected by authors who are noted to be blind until data analysis |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes reported. “Analysis by intention to treat”. Page 747 |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias noted. Protocol not available |
Other bias | Low risk | No evidence of other bias noted. Protocol not available |