Nielsen 2005.
Methods | RCT | |
Participants | Number of women randomised: 226
Setting: Army Medical Center, Tacoma, Washington, USA Inclusion criteria
Exclusion criteria
State of cervix: favourable (≥ 5 for nulliparous and ≥ 4 for multiparous women) |
|
Interventions |
Induction group (n = 116): AROM, oxytocin or both versus Expectant management group (n = 110): weekly follow‐up until 42 weeks. Labour induced after 42 weeks. Weekly monitoring with CTG and ultrasound, increased to twice a week after 41 weeks. |
|
Outcomes |
Mother: randomisation to birth interval; admission to birth interval; Indication for admission; epidural analgesia; mode of birth; EBL; length of labour; chorioamnionitis; postpartum days Baby: birthweight; admission to NICU; Apgar score < 7 at 5 mins |
|
Notes | The study was discontinued after recruitment of 226 women (target of 600) due to slow recruitment and no observed difference in the 2 groups Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation sequence was generated using a computer‐generated list. |
Allocation concealment (selection bias) | Low risk | Allocation concealment was achieved using sequentially numbered, opaque, sealed 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. 23/116 (19.8%) in induction group went into spontaneous labour, 10/110 (9.1%) in the expectant management group required labour induction and results for these women were analysed according to which group they were randomised. |
Selective reporting (reporting bias) | Unclear risk | No access to trial protocol for confidently assess selective reporting. Perinatal death not reported. |
Other bias | Unclear risk | Baseline imbalance for Bishop score "The only significant difference noted was EM patients had a more favorable Bishop score on admission than IND patients (7.2+2.1 versus 8.6+2.0, p<0.0001)." |