| Methods |
RCT. |
| Participants |
277 women. PROM, primips, GA 36‐41 wks, singleton, cephalic, cx dilatation < 4 cm, admission within 3‐5 hrs of PROM. |
| Interventions |
IV oxytocin 5‐7 hrs post ROM
vs
expectant management x 56‐80 hrs, then IV oxytocin if still not in labour. |
| Outcomes |
C/S, perinatal death, epidural analgesia, instrumental vaginal delivery, Apgar score < 7 at 5 minutes, Apgar < 7 at 1 minute, chorioamnionitis, endometritis, neonatal infection, neonatal jaundice, retained placenta. |
| Notes |
'Simple randomisation'. Sealed envelopes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as "simple randomisation". |
| Allocation concealment? |
Unclear risk |
Sealed envelopes in labour ward. |
| Blinding?
Women |
High risk |
Not feasible. |
| Blinding?
clinical staff |
High risk |
|
| Blinding?
outcome assessor |
High risk |
|
| Incomplete outcome data addressed?
All outcomes |
High risk |
Attrition not balanced between groups. |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Unclear risk |
Long recruitment period and high non‐participation rate. |
