OBJECTIVE: To compare the clinical effectiveness and safety of intracervical dinoprostone versus conservative management of term prelabor rupture of membranes. SUBJECTS AND METHODS: 88 women with term prelabor rupture of membranes were assigned randomly to one of two groups RESULTS:44 women were allocated in each group. The means (+/- S. D) intervals from PROM to delivery and from inclusion to start of labour were significantly shorter in the dinoprostone group (19.5+/-6.2 vs 25.5+/-7.7 hours p<0.01 and 8.7+/-5.5 hours vs 14+/-6. 8; p=0.32 respectively). No significant differences were observed in the mean duration of labour (4.5+/-1.6 hours vs. 4.9+/-1.67 p=0.32). The rates of clinical amniotits were 15.9% in the dinoprostone group and 6.8% in the control group; difference is not statistically significant (p=0.17). The mode of delivery and Apgar score were similar in the two groups. Uterine tachysystole occurred more frequently in the dinoprostone group (6.8 vs 0%) but did not reach statistical significance. CONCLUSION: Intracervical administration of dinoprostone with prelabor rupture of membrane at term and unripened cervix shortens the interval to delivery without a significant increase of maternal or neonatal morbidity.
RCT Entities:
OBJECTIVE: To compare the clinical effectiveness and safety of intracervical dinoprostone versus conservative management of term prelabor rupture of membranes. SUBJECTS AND METHODS: 88 women with term prelabor rupture of membranes were assigned randomly to one of two groups RESULTS: 44 women were allocated in each group. The means (+/- S. D) intervals from PROM to delivery and from inclusion to start of labour were significantly shorter in the dinoprostone group (19.5+/-6.2 vs 25.5+/-7.7 hours p<0.01 and 8.7+/-5.5 hours vs 14+/-6. 8; p=0.32 respectively). No significant differences were observed in the mean duration of labour (4.5+/-1.6 hours vs. 4.9+/-1.67 p=0.32). The rates of clinical amniotits were 15.9% in the dinoprostone group and 6.8% in the control group; difference is not statistically significant (p=0.17). The mode of delivery and Apgar score were similar in the two groups. Uterine tachysystole occurred more frequently in the dinoprostone group (6.8 vs 0%) but did not reach statistical significance. CONCLUSION: Intracervical administration of dinoprostone with prelabor rupture of membrane at term and unripened cervix shortens the interval to delivery without a significant increase of maternal or neonatal morbidity.