Roach 1997.
Methods | RCT | |
Participants | Number of women randomised: 201
Setting: Hong Kong, China Inclusion criteria
Exclusion criteria
State of cervix: not mentioned as a criterion |
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Interventions |
Induction group (n = 96): PGE2 pessaries 6‐hourly if necessary versus Expectant management group (n = 105): serial monitoring with NST (x2) and amniotic fluid index measurements (x1) weekly. |
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Outcomes |
Mother: spontaneous labour; caesarean section; fetal distress in labour Baby: birthweight; Apgar score < 7 (1 min/5 min); cord blood pH; admission to NICU; meconium below the vocal cords |
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Notes |
Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Allocation in a series of identical envelopes but no mention of sealed envelopes, opaqueness and sequential numbered envelopes. |
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 | No apparent losses to follow‐up or exclusions. 17/96 (18%) in the induction group went into spontaneous labour and 12/105 (11%) in the expectant management group were induced and the results for these women were included in the analyses. |
Selective reporting (reporting bias) | Unclear risk | Very few outcomes reported; "We did not address perinatal mortality in this study." No access to trial protocol to further assess selective reporting. |
Other bias | Low risk | Appears to be free of other bias. |