| Methods |
RCT. |
| Participants |
118 women with PROM < 12 hrs, GA 35‐42 wks, singleton, cephalic, no evidence of infection. |
| Interventions |
IV oxytocin, immediate. 1 mU with increments of 1mU every 20 minutes to a maximum of 24 mU
vs
intracervical PGE2 0.5 mg q8h x 3, then IV oxytocin if still not in labour. |
| Outcomes |
C/S, serious maternal morbidity or death, Apgar score < 7 at 5 minutes, perinatal death excluding major congenital malformations, chorioamnionitis, endometritis, neonatal infection. |
| Notes |
Computer‐generated set of random assignments.
Open label. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated random numbers. |
| Allocation concealment? |
Unclear risk |
Staff informed of allocation but this was after group asignment. |
| Blinding?
Women |
High risk |
Different treatment protocols. |
| Blinding?
clinical staff |
High risk |
|
| Blinding?
outcome assessor |
High risk |
|
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No loss to follow up apparent. |
| Free of selective reporting? |
Low risk |
|
