The effect of drotaverine (NO-SPA) on the dilatatory phase of physiological uncomplicated deliveries

An open, randomized, controlled study was performed in order to investigate the effect of intramuscularly administered drotaverine (NO-SPA) onto some parameters of physiological delivery, i.e. the time duration of the dilatatory phase, the number of cervical tears. 200 healthy women were enrolled. All patients completed the study according to the protocol. The demographic data of Group A - the drotaverine group and Group B - the control were identical. The average duration of the dilatatory phase - in minutes - was 183.6 ± 121.1 in Group A, whereas it was 236.2 ± 138.6 in Group B. The difference was significant (p = 0.005). The number of cervical tears were: 2 unilateral and 1 bilateral in Group A and at the same time 27 unilateral and 34 bilateral in Group B (untreated) this difference being highly significant (p = 0.001). The length of the second and third stage as well as the total time duration of delivery did not show a significant difference. The average time till cessation of delivery pain (in minutes) was 116.4 ± 71 in Group A and 171.1 ± 86.3 in Group B, the difference statistically significant (0.001). The maximal intensity of delivery pain was significantly higher (p = 0.05) in Group A, but there was no difference in the average pain between the two groups. There were no differences between the two groups in terms of the heart rate, blood pressure and perinatal blood loss. The APGAR scores were above 9.5 and there was a statistically' significant difference in favor of Group A but this has no clinical significance. Serious adverse events were not observed during the study.