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

NCT02098889 | Completed Phase 4

• 1 other identifier: 179
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cervix, active phase of labor, Hyoscine-N-Butylbromide (HBB)

Outcome Measures

Primary Outcomes (1)

• Effect of HBB on the active management of labor

  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'.

  up to 7 month

Secondary Outcomes (2)

• Safety and efficacy of HBB on maternal outcomes

  up to 7 month

• Safety and efficacy of HBB on fetal outcomes

  up to 7 month

Study Arms (2)

hyoscine-N-butyl bromide

ACTIVE COMPARATOR

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

Drug: hyoscine-N-butyl bromide(HBB)

Saline(0,9NaCl)

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

hyoscine-N-butyl bromide(HBB) DRUG

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

Also known as: Molit amp.

hyoscine-N-butyl bromide

Saline DRUG

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

Also known as: 0,9NaCl

Saline(0,9NaCl)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Etfal Research and Training hospital, Obstetrics and gynecology department

Istanbul, Marmara, 34100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Osman Asıcıoglu

  Serpil KIRIM,Begum AYDOGAN,Nazlı YENIGUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 28, 2014
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 28, 2014

Record last verified: 2012-05

Locations

TU (1)