Bergsjo 1989.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 188 Setting: Wuhan, Hubei province, China Study date: study conducted 1 July 1982 to January 1985 (enrolment ended early 1984) Inclusion criteria
Exclusion criteria
State of cervix: not mentioned |
|
Interventions |
Induction group (n = 94): stripping of membranes followed by oxytocin infusion and AROM if cervix sufficiently dilated. GA for intervention: 42 completed weeks (294 days) versus EM group (n = 94): no intervention for 1 week, IOL at 43 weeks. |
|
Outcomes |
Mother: operative vaginal birth; duration of labour; caesarean section; breastfeeding (timing of recording of this outcome in relation to birth or discharge time was not specified) Baby: perinatal death; meconium aspiration syndrome |
|
Notes |
Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | List of random numbers |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinded outcome assessment was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/94 in IOL group went into labour before IOL but were kept in the allocated group. No apparent losses to follow‐up or exclusions |
Selective reporting (reporting bias) | High risk | Most prespecified outcomes were reported; however, limited information was provided for some outcomes (e.g. combined maternal complications) and neonatal outcomes, e.g. "Maternal complications, including protracted labour, cervical edema, cervical laceration, postpartum hemorrhage and unspecified postpartum morbidity accounted to about 15% in both groups, with no significant differences;" and "About 90 mothers in each group were breastfeeding." |
Other bias | Low risk | Appeared to be free of other bias |