Zamzami 2014.
Methods | Randomised controlled trial | |
Participants |
Setting: Antenatal clinic, King Abdulaziz University Hospital, Jeddah, Saudi Arabia. Duration of study: 1 January 2011 to 1 January 1 2012 Participants randomised: N = 160 Inclusion criteria: “singleton pregnancy, cephalic presentation, and anticipated vaginal delivery (Page 30). Exclusion criteria: “indications for induction of labor, indications for cesarean section, and contraindications to membrane sweeping, such as multiple gestation, placenta previa, placental abruption, history of preterm delivery, vasa previa, active cervical infection, Mullerian anomalies, severe fetal anomalies and active herpes infection.” (Page 30). Parity: mixed. Both nulliparous and multiparous women included (Table II, Page 32). Bishop score: Bishop score (Initial), mean SD (Table II, Page 32). Bishop score on admission to LW, mean SD |
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Interventions |
Membrane stripping (N = 80): "All membrane sweeping group was performed by one clinician investigator and women allocated to control group received routine monitoring; in each case, the cervix was dilated and the health provider swept a finger in a 360° manner inside the cervix, thereby separating the lower uterine segment from the amniotic sac. If the cervix was closed, it was massaged digitally.” Modified Bishop scoring were determine as the following; cervical dilatation, effacement and fetal station" (Page 31). Control group (N = 80): no sweep (Page 31). All pregnant women “both groups” who did not enter spontaneous labor or remaining undelivered at 41 weeks' gestation were being admitted and underwent for induction of labour. |
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Outcomes | Induction (at 41 weeks) Spontaneous labour (< 41 weeks) SVD Vacuum delivery Caesarean section Apgar score < 7 PPH |
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Notes |
Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: yes, “provided written informed consent from all participants.” (Page 31). Ethical approval: yes "approved by the Biomedical Ethics Research Committee and Human Investigation “according to principles of Helsinki Declaration” at King Abdulaziz University" (Page 30). Email sent 28 August 2017 requesting information. Resent 10 September 2017. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Women were assigned randomly at 38 weeks“ “using computer‐generated numbers”, page 31. |
Allocation concealment (selection bias) | Low risk | “allocation concealed in opaque sealed envelopes that were drawn in order.”, page 31. |
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. 80 women excluded pre randomisation (60 declined to participate, 20 did not meet inclusion criteria). All outcomes reported on “intention to treat” analysis, page 31. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting noted. All outcomes reported in methods reported in results, page 33. |
Other bias | Low risk | No evidence of other bias |
AFI: amniotic fluid index CS: low segment caesarean section CMS: cervical membrane stripping CTG: cardiotocography GA: gestational age GBS: group B Streptococcus IU: international unit IV: intravenous LW: labour ward NST: non stress test PGE2: prostaglandin E2 PPH: postpartum haemorrhage PPI: present pain index PROM: prelabour rupture of membrane RCT: randomised controlled trial SD: standard deviation SEM: standard error of the mean TTN: transient tachypnea of the newborn VAS: visual analogue scale VBAC: vaginal birth after caesarean section