| Methods |
RCT. |
| Participants |
1012 women with PROM, GA > 34 wks, singleton, cephalic, no chorioamnionitis. |
| Interventions |
IV oxytocin, 2‐24 hrs post‐randomisation. 2.5 mU per minute increasing by 2.5 mU per minute every 30 minutes
vs
expectant management, then IV oxytocin 50‐72 hrs post‐randomisation if still not in labour. |
| Outcomes |
C/S, perinatal death, epidural analgesia, instrumental vaginal delivery, Apgar < 7 at 5 minutes, admission to NICU, chorioamnionitis, endometritis, neonatal antibiotics. |
| Notes |
Computer‐generated list of random numbers. Sealed opaque sequentially numbered envelopes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated list of random numbers. |
| Allocation concealment? |
Low risk |
Sealed, opaque envelopes. |
| Blinding?
Women |
High risk |
Not feasible. Different treatment regimes. |
| Blinding?
clinical staff |
High risk |
|
| Blinding?
outcome assessor |
High risk |
|
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
| Free of other bias? |
Unclear risk |
Results were difficult to interpret. |
