Moustafa I Ibrahim1, Hazem A Alzeeniny1, Mohamed I Ellaithy2, Ahmed H Salama1, Mohammed A Abdellatif3. 1. Department of Obstetrics and Gynecology, Ain-shams Faculty of Medicine, Cairo, Egypt. 2. Department of Obstetrics and Gynecology, Ain-shams Faculty of Medicine, Cairo, Egypt. Electronic address: drmellisy@hotmail.com. 3. Department of Obstetrics and Gynecology, Sohag Teaching Hospital, Sohag, Egypt.
Abstract
OBJECTIVE: To reevaluate the role of the antispasmodic drug drotaverine in shortening the length of the active first stage of labor among nulliparous women. METHODS: In a randomized, double-blind, placebo-controlled trial, 422 young nulliparous women admitted to Ain-shams University Maternity Hospital, Cairo, Egypt, in spontaneous labor were initially enrolled between May and December 2012. Drotaverine hydrochloride (40mg) or placebo was given at the start of the active phase of labor and then repeated every 2hours (maximum 3 doses). All participants were consistently managed in accordance with the local institutional intrapartum protocol. The primary outcome was the rate of cervical dilation. RESULTS: After excluding women who delivered by cesarean, data were analyzed from 320 women. There was a significant difference in post-treatment labor pain scores, duration of the active phase of labor, and rate of cervical dilatation between the 2 groups (P<0.001 for all). There was no difference in maternal adverse effects. Kaplan-Meier survival analysis showed a greater probability of faster delivery among patients treated by drotaverine hydrochloride (log rank test; P<0.001). CONCLUSION:Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of labor among nulliparous women with active spontaneous labor. ClinicalTrials.gov: NCT01639027.
RCT Entities:
OBJECTIVE: To reevaluate the role of the antispasmodic drug drotaverine in shortening the length of the active first stage of labor among nulliparous women. METHODS: In a randomized, double-blind, placebo-controlled trial, 422 young nulliparous women admitted to Ain-shams University Maternity Hospital, Cairo, Egypt, in spontaneous labor were initially enrolled between May and December 2012. Drotaverine hydrochloride (40mg) or placebo was given at the start of the active phase of labor and then repeated every 2hours (maximum 3 doses). All participants were consistently managed in accordance with the local institutional intrapartum protocol. The primary outcome was the rate of cervical dilation. RESULTS: After excluding women who delivered by cesarean, data were analyzed from 320 women. There was a significant difference in post-treatment labor pain scores, duration of the active phase of labor, and rate of cervical dilatation between the 2 groups (P<0.001 for all). There was no difference in maternal adverse effects. Kaplan-Meier survival analysis showed a greater probability of faster delivery among patients treated by drotaverine hydrochloride (log rank test; P<0.001). CONCLUSION:Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of labor among nulliparous women with active spontaneous labor. ClinicalTrials.gov: NCT01639027.