Ahmed M Maged1, Ehab H Sorour2, Mostafa M ElSadek2, Sarah M Hassan2, Amira Y Shoab2. 1. Obstetrics and Gynecology Department, Kasr AlAini Hospital Cairo University, 11 Eid Mostafa from King Faisal Street Haram Giza, Cairo, 12111, Egypt. prof.ahmedmaged@gmail.com. 2. Obstetrics and Gynecology Department, Kasr AlAini Hospital Cairo University, 11 Eid Mostafa from King Faisal Street Haram Giza, Cairo, 12111, Egypt.
Abstract
OBJECTIVE: To assess the safety and efficacy of hyoscine butyl bromide (HBB) in primipara with prolonged 1st stage of labor. MATERIALS AND METHODS: A double-blinded randomized controlled trial included 100 primiparas diagnosed with prolonged labor. They were randomly divided two equal groups. Group I received 40 mg HBB intravenously. Group II received 2 ml of normal saline. The primary outcome was the duration of the 1st stage of labor. Secondary outcomes included success of vaginal delivery, rate of cervical dilation, duration of 2nd and 3rd stages of labor, causes of CS, neonatal outcome and drug side effects. RESULTS: The duration of the 1st stage was 322.3 ± 89.8 min in women who received HBB compared with 451.3 ± 198.3 min in the control women (P < 0.001). The rate of cervical dilation was increased from 0.4 ± 0.2 to 1.5 ± 0.6 in women who received HBB compared with its increase from 0.4 ± 0.1 to 0.9 ± 0.2 in other women (P < 0.001). The rate of CS were significantly higher in control women when compared to those received HBB (34 vs. 20%, P < 0.001). The commonest indication for the operation was arrest of cervical dilatation (28 and 16%, respectively). CONCLUSION:HBB is associated with shortening of the 1st stage, lowered rate of CS without any side effects. GOV ID: NCT03430362 date of registration 6 February 2018. Synopsis Hyoscine butyl bromide is associated with shortening of the 1st stage, lowered rate of CS in primiparas with prolonged labor.
RCT Entities:
OBJECTIVE: To assess the safety and efficacy of hyoscine butyl bromide (HBB) in primipara with prolonged 1st stage of labor. MATERIALS AND METHODS: A double-blinded randomized controlled trial included 100 primiparas diagnosed with prolonged labor. They were randomly divided two equal groups. Group I received 40 mg HBB intravenously. Group II received 2 ml of normal saline. The primary outcome was the duration of the 1st stage of labor. Secondary outcomes included success of vaginal delivery, rate of cervical dilation, duration of 2nd and 3rd stages of labor, causes of CS, neonatal outcome and drug side effects. RESULTS: The duration of the 1st stage was 322.3 ± 89.8 min in women who received HBB compared with 451.3 ± 198.3 min in the control women (P < 0.001). The rate of cervical dilation was increased from 0.4 ± 0.2 to 1.5 ± 0.6 in women who received HBB compared with its increase from 0.4 ± 0.1 to 0.9 ± 0.2 in other women (P < 0.001). The rate of CS were significantly higher in control women when compared to those received HBB (34 vs. 20%, P < 0.001). The commonest indication for the operation was arrest of cervical dilatation (28 and 16%, respectively). CONCLUSION:HBB is associated with shortening of the 1st stage, lowered rate of CS without any side effects. GOV ID: NCT03430362 date of registration 6 February 2018. Synopsis Hyoscine butyl bromide is associated with shortening of the 1st stage, lowered rate of CS in primiparas with prolonged labor.