Martin 1978.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 264 "admitted to this trial"
Setting: Royal Maternity Hospital, Northern Ireland, UK Study date: not reported Inclusion criteria
Exclusion criteria
State of cervix: not clearly reported; assumed to be mixed (Bishop score recorded). |
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Interventions |
Induction group (n = 131 admitted; 92 analysed): IOL at 39 weeks' GA. Women were admitted for fasting at 8:30 am; their forewaters were punctured soon after and Bishop score and cervical dilatation recorded. IV oxytocin commenced at 2.5 mU/minute and doubled every 30 minute until satisfactory uterine response achieved; dose varied to maintain adequate contractions. All women continuously monitored with internal tocography and fetal scalp electrode. versus EM group (n = 133 admitted; 92 analysed): await spontaneous labour until 42 weeks, unless IOL required earlier for medical reasons. Women had, if necessary, augmentation of labour by puncture of the forewaters or IV oxytocin; when possible, they were also monitored. |
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Outcomes |
Mother: mode of birth (assisted birth; caesarean birth); induction to birth interval; unexplained postpartum pyrexia; analgesia demand; type 1 and 2 diabetes; meconium staining of the amniotic fluid; duration of gestation; attitudes towards management Baby: Apgar scores at 1 and 5 minutes; Dubowitz scores < 45; stillbirth; hyperbilirubinaemia |
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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) | Low risk | "A prospective randomized controlled trial"; "allocated using random number tables." |
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 | Low risk | “All monitor records were examined blind at completion of the trial.” |
Incomplete outcome data (attrition bias) All outcomes | High risk | 184/264 women followed up (30% loss to follow‐up). 264 women eligible, 34 excluded: induction group: obstetric abnormality (8 women); refusal (10 women); defaulter (6 women); spontaneous labour before attending clinic (1 woman). EM group: obstetric reasons (9); leaving 230 women in the trial (106 in planned birth, 124 in EM group) Of the 106 women in the induction group, 13 went into spontaneous labour before the date of admission and 1 was excluded due to medical reasons – therefore 92 women were induced and analysed. Of the 124 women in the EM group, a further 32 were excluded due to obstetric abnormalities or failure to go into spontaneous labour before 42 weeks – therefore only 92 were analysed. |
Selective reporting (reporting bias) | Unclear risk | Some results reported incompletely, e.g.: “There was no difference with respect to the distribution of Apgar scores…at five minutes.” |
Other bias | Unclear risk | Groups appeared comparable at baseline however analyses excluded 30% of women admitted to the trial. Limited methodological detail provided to further assess other bias |