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Completed

NCT Number: NCT07474350

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valethamate Bromide

Drug

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

Hyoscine Butylbromide

Drug

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

Sterile Water

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal Teaching Hospital Abakaliki

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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