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

NCT02098889 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2014-03-28

No results posted yet for this study

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.

Conditions

  • Labor Fast

Interventions

DRUG

hyoscine-N-butyl bromide(HBB)

A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB) versus placebo ( a single dose of 20ml IV NaCl) on the active phase of labor

DRUG

Saline

placebo ( a single dose of 20ml IV NaCl) versus A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB)on the active phase of labor

Sponsors & Collaborators

  • Sisli Hamidiye Etfal Training and Research Hospital

    lead OTHER

Principal Investigators

  • Osman Asıcıoglu · Serpil KIRIM,Begum AYDOGAN,Nazlı YENIGUL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098889 on ClinicalTrials.gov