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

NCT07474350 | Completed

• 1 other identifier: AE FUTHA/REC/VOL3/2023/236
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primigravida; Labour Duration

Keywords

Valethamate bromide; Hyoscine butyl bromide; Primigravida; Labour duration

Outcome Measures

Primary Outcomes (1)

• Rate of cervical dilatation

  This was the rate of dilation of the cervix per hour in patients in active phase of labour

  8hours

Study Arms (3)

Valethamate

EXPERIMENTAL

Group I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour.

Drug: Valethamate Bromide

Hyoscine

ACTIVE COMPARATOR

Group II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour.

Drug: Hyoscine butylbromide

Water

SHAM COMPARATOR

Group III received 2ml of sterile water for injection when patient is in active phase of labour

Other: Sterile water

Interventions

Valethamate Bromide DRUG

Two ml (16mg) of valethamate bromide was given intravenously to the patient who has attained active phase labour parameters

Valethamate

Hyoscine butylbromide DRUG

Two ml (40mg) of hyoscine butylbromide was given intravenously to the patient who has attained active phase labour parameters

Hyoscine

Sterile water OTHER

Two ml of water was given intravenously to the patient who has attained active phase labour parameters

Water

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Interventions

valethamate; Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Assumpta N Nweke

  Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: September 1, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)