Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida

March 11, 2026 updated by: Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki

Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida: A Randomised Controlled Trial.

Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability.

This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. When labour is prolonged, it may defeat the whole essence of pregnancy as a result of poor outcome. Efforts have been made to prevent prolonged labour which includes the use of certain medications such as hyoscinebutyl bromide and valethamate bromide. However, there is paucity of studies comparing the effectiveness of both drugs, which could provide a better choice of reducing labour duration and its attendants' complications.

AIM:

This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki.

RESEARCH METHOD:

This was a randomized controlled study where equal members of primigravid women at term were recruited and received 8 mg (2 ml) of valethamatebromide;20 mg (2 ml) of hyoscine butyl bromideand 2ml of sterile water.

Either valethamate bromide 8mg, hyoscine butyl bromide20mg and no intervention (2 ml of sterile water) were given intravenously to the women who met the criteria. The data obtained were analyzed using statistical package for social science (SPSS) software (version 2022, Chicago II, USA). Categorical variables were presented as numbers and percentages while continuous variables were presented as mean and standard deviation (mean + 25D). Logistic regression was used where appropriate. A difference with a P value of ≤ 0.05 was taken to be statistically significant.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Ebonyi State
      • Abakaliki, Ebonyi State, Nigeria, 480101
        • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primigravidae / nulliparae.
  • Singleton term pregnancy with no evidence of maternal or fetal distress.
  • Women with fetus in cephalic presentation.
  • Age: 18- 35 years.
  • Women with no contra-indications to vaginal delivery.
  • Cervical dilatations of 4- 9cm when in labour
  • Spontaneous or induced labour.
  • Patients on epidural analgesia

Exclusion Criteria:

  • Multiple gestations.
  • Women with abnormal fetal presentation.
  • Absolute indications for caesarean section.
  • Antepartum hemorrhage.
  • Evidence of maternal or fetal distress.
  • Fibroid in pregnancy.
  • Grand multiparous patients.
  • Previous uterine scar/ surgery or ruptures.
  • Medical disorders of pregnancy like pre-eclempsia, Eclempsia, Dm etc.
  • If any other antispasmodics agent had been used within the last 48 hours.
  • Preterm/ term premature rupture of membranes.
  • History of cervical injury/ surgery.
  • Hypersensitivity to valethamate bromide and/or hyoscine butyl bromide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valethamate
Group I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour.
Drug: Valethamate Bromide
Two ml (16mg) of valethamate bromide was given intravenously to the patient who has attained active phase labour parameters
Active Comparator: Hyoscine
Group II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour.
Drug: Hyoscine butylbromide
Two ml (40mg) of hyoscine butylbromide was given intravenously to the patient who has attained active phase labour parameters
Sham Comparator: Water
Group III received 2ml of sterile water for injection when patient is in active phase of labour
Other: Sterile water
Two ml of water was given intravenously to the patient who has attained active phase labour parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cervical dilatation
Time Frame: 8hours
This was the rate of dilation of the cervix per hour in patients in active phase of labour
8hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Teaching Hospital Abakaliki

Investigators

  • Principal Investigator: Assumpta N Nweke, Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AE FUTHA/REC/VOL3/2023/236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This will be after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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