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Efficacy and Safety of Hyoscine N Butyl Bromide on the Augmentation of Labor: a Double-Blind, Placebo - Controlled Trial (HBB)
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.
Details
| Lead sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 382 |
| Start date | 2012-05 |
| Completion | 2012-11 |
Conditions
- Labor Fast
Interventions
- hyoscine-N-butyl bromide(HBB)
- Saline
Primary outcomes
- Effect of HBB on the active management of labor — up to 7 month
The aim of the active management of labor is to shorten the duration of labor without an increase in maternal or fetal morbidity and mortality. Appropriate cervical dilatation and effacement are essential for the progression of labor. Our study designed to evaluate the effects of HBB on cervical dilatation and demonstrated the efficacy of HBB in augmenting labor. We are going to measure cervical effacement and dilation in every 2 hours to evaluate the progression of labor. To evaluate the effect of HBB on active phase of labor, we will measure the time (in minutes) between the active phase of labor and delivery.The measured time difference is going to give us 'does HBB has any effects on the shortening of active phase of labor'.
Countries
Turkey (Türkiye)