A prospective, single center study on clinical safety and efficacy of Dinoprostone gel for cervical ripening in pregnant women not in labor


Objective: To determine the safety of dinoprostone gel and clinical efficacy for cervical ripening among women for labor induction with a Bishop score of less than 9

Methodology: This is a propsective, single center study where 165 women with a singleton pregnancy, cephalic presentation, at ≥ 36 weeks AOG, candidates for labor induction, and with a Bishop score of less than 9 were subjected to cervical ripening using dinoprostone gel. The primary outcomes were induction success rate, spontaneous vaginal delivery rate, number of dinoprostone gel used and length of time to achieve induction success and deliver.

Results: A median of 1 (range 1-3) dinoprostone gels were used per woman. The median intervals from labor induction to active labor and termination of pregnancy were 260 (range 0-2480) and 485 (range 0-2950) minutes, respectively. The median intervals from dinoprostone insertion to active labor and termination of pregnancy were 480 (range 60-2480) and 820 (range 134-3310) minutes, respectively. Labor was successfully induced in 83%. No adverse events were noted. No significant differences based on parity were detected for the outcomes of dinoprostone dosage and mode of delivery, although in terms of relative proportion, more multiparous women gave birth normally (69% vs. 57%, P = 0.226). There was, however, evidence of increased induction success among women who have given birth previously (94% vs 79%, P = 0.022). The success group generally had higher Bishop scores (i.e. success group had predominantly Bishop 4 and up scores) and higher ages of gestation, more than 50% term patients. There was insufficient evidence to demonstrate a difference between the AOG groups. The duration from labor induction to active phase of labor was shorter for those with BS > 4 (median 240 versus 265 minutes), while the duration from labor induction to termination of pregnancy was shorter for BS ≤ 4 points (478 mins vs 510 mins). However, these were not statistically significant. Similarly, the duration from Dinoprostone insertion to active phase of labor was shorter for those with BS > 4 (median 420 versus 502.5 minutes). The duration from Dinoprostone insertion to termination of pregnancy was also shorter for BS > 4 points (685 mins vs 835 mins). However, these were not statistically significant. The median time from labor induction to active phase was 260 minutes (95% CI 210 to 360 minutes). The median time from labor induction to termination was 490 minutes (95% CI 434 to 590 minutes). None of the following were reported: tachysystole, nausea/ vomiting, diarrhea, vaginal irritations, abdominal pain, back pain, headache, dizziness.

Conclusion: The use of dinoprostone gel is safe. No adverse events have been reported. Induction success was at 83.03%. Vaginal delivery was achieved by 66.67% of the population. Significantly higher induction success and higher vaginal delivery rates were seen for parous group.

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