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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07474350
Enrollment
165
Registered
2026-03-16
Start date
2023-09-01
Completion date
2024-01-23
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Duration, Primigravida

Keywords

Valethamate bromide, Hyoscine butyl bromide, Primigravida, Labour duration

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

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.

Interventions

DRUGValethamate Bromide

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

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

OTHERSterile water

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

Sponsors

Federal Teaching Hospital Abakaliki
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of cervical dilatation8hoursThis was the rate of dilation of the cervix per hour in patients in active phase of labour

Countries

Nigeria

Contacts

PRINCIPAL_INVESTIGATORAssumpta N Nweke

Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026