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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal Teaching Hospital Abakaliki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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