Safety Study of Hyoscine N Butyl Bromide in Active Management of Labor
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Sisli Etfal Training & Research Hospital Sisli Hamidiye Etfal Training and Research Hospital