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

Federal Teaching Hospital Abakaliki

Status: Completed

Conditions: Primigravida; Labour Duration

Treatments: Drug: Valethamate Bromide; Drug: Hyoscine butylbromide; Other: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT07474350

AE FUTHA/REC/VOL3/2023/236

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 3 patient groups

Valethamate

Experimental group

Description:

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

Treatment:

Drug: Valethamate Bromide

Hyoscine

Active Comparator group

Description:

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

Treatment:

Drug: Hyoscine butylbromide

Water

Sham Comparator group

Description:

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

Treatment:

Other: Sterile water