| Methods |
RCT. |
| Participants |
60 women with PROM, GA > 36 wks, Bishop score < 8. |
| Interventions |
IV oxytocin, 10 hrs post ROM
vs
intracervical PGE2 0.4 mg, 10 hrs post ROM, then q24h until labour. |
| Outcomes |
C/S, instrumental vaginal delivery, Apgar < 7 at 5 minutes, neonatal infection. |
| Notes |
No mention of randomisation technique or allocation concealment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
No information provided. |
| Allocation concealment? |
Unclear risk |
Described as "randomly divided". |
| Blinding?
Women |
High risk |
|
| Blinding?
clinical staff |
High risk |
|
| Blinding?
outcome assessor |
High risk |
|
| Free of other bias? |
Unclear risk |
Change in protocol during the study. Unequal group sizes (25 vs 35) not explained. |
