Safety Study of Hyoscine N Butyl Bromide in Active Management of Labor

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Although Hyoscine N butyl bromide (HBB) is used liberally to facilitate cervical dilatation, there is little and inconclusive data about its efficacy. The aim of this study was to determine the efficacy and safety of HBB on the augmentation of labor.420 of total 1640 pregnant women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 37-41 gestational weeks, active phase (cervical dilatation: 4 cm, cervical effacement: %50 or more) of spontaneous labor with vertex presentation enrolled to study. 382 of them were included in this study. Patients were randomized to receive intravenously(IV) either 20 mg/ml HBB or a similar amount of placebo (1 ml 0.9% NaCl) at the beginning of the active phase of labor. The medications applied as single dose. The time elapsed until the second stage of labor, second stage and third stage were measured.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sisli Etfal Training & Research Hospital; Sisli Hamidiye Etfal Training and Research Hospital
• Treatments: Bromides; Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

Criteria

Inclusion Criteria:

• Singleton, vertex presentation at term (gestational age range; 37-41weeks) primigravid and multigravid women without any chronic and pregnancy-induced diseases

Exclusion Criteria:

• The cases with premature rupture of membranes, preeclampsia, eclampsia, placental abruption, placenta previa, abnormal placental attachment, twin pregnancy, non- cephalic presentations, previous uterine surgery and cephalopelvic disproportion