Dare 2002.
Methods | Randomised controlled trial | |
Participants |
Setting: Owolowo University teaching hospitals, Ile‐lfe, Nigeria Duration of study: 18 months (1 January 1998 to 31 May 2000) Inclusion criteria: “Singleton gestation in the cephalic presentation at 38 weeks gestation, early confirmation of pregnancy by ultrasonography and no contraindications to vaginal delivery” Page 283 Exclusion criteria: “closed cervix not amenable to stripping at 38 weeks gestation, placenta praevia, medical complications of pregnancy such as insulin dependent diabetes mellitus, rupture of fetal membranes, unexplained vaginal bleeding, intrauterine growth restriction or a prior uterine incision” Page 283 Parity: mixed. both nulliparous and multiparous women included (% presented in Table 1 of manuscript page 284). Bishop score: recorded (% presented in Table 1 of manuscript page 284). |
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Interventions |
Membrane sweep (n = 69): “membrane stripping” “Stripping of the membranes was performed by separating approximately 2‐3cm of chorionic membranes from the lower uterine segment using two circumferential passes of the examining finger” Page 283 Control group (n = 68): “gentle cervical examination” Page 283 “All patients were examined by the same person to minimise subjective differences in evaluation. Bishop scores were recorded for all patients” Membranes stripping or gentle cervical examination, performed by 1 clinician. |
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Outcomes | Spontaneous vaginal delivery Assisted delivery Caesarean section Chorioamnionitis Apgar score < 7 at 5 minutes Neonatal death (congenital heart defects) |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained:“all candidates gave signed informed consent before randomization” Ethical approval: yes; “This study was approved by the hospital ethical committee on human investigation” Email sent 30 August 2017, 26 October 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 | “computer‐generated random schedule”. Page 283 |
Allocation concealment (selection bias) | Low risk | “The allocation of assignment was concealed by placement in a numbered, opaque sealed envelope which was drawn in consecutive order”. Page 283 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not discussed Personnel: “examined by the same person to minimise subjective differences in evaluation” Page 283 |
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.“One hundred and sixty‐nine women were eligible for the study of whom 11 (6%) declined to participate. Of the 158 who signed the consent, nine were lost to follow‐up and 12 were excluded because of long, closed cervices not amenable to stripping” < 20%". Page 284 |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias. |
Other bias | Low risk | No evidence of other bias. |