The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

National University of Malaysia110 enrolled

Overview

This study compares the duration of active phase of labour in women who received buscopan and those who don't.

A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Labor Long

Interventions

Hyoscine ButylbromideDRUG

Intervention is given once a participant is in established labor

PlaceboOTHER

Intervention is given once a participant is in established labor

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Primigravida * Vertex presentation * Term gestation (37-41w) * Active phase of labor (4cm with regular contraction at least 2:10) * Spontaneous labor * Oxytocin augmentation * Maternal height ≥150cm Exclusion Criteria: * Multiple pregnancies * Previous uterine surgery * Hypertensive disease in pregnancy * Gestational diabetes on treatment * Clinical estimation of fetal weight \>3.8kg * Induction of labor * Meconium stained liquor * Allergy to hyoscine * Medical contraindication to hyoscine (i.e Myasthenia gravis, glaucoma, megacolon)

Locations (1)

National University Malaysia Medical Centre

Cheras, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Labor length

Duration of labor

Time frame: Through study completion until delivery up to 12 hours

Secondary Outcomes

Maternal age

Mean maternal age in years

Time frame: At the time of recruitment

Gestational age

Mean gestational age in weeks

Time frame: At the time of recruitment

Pre-pregnancy body mass index

Mean body mass index in kg/m2

Time frame: At the time of recruitment

First stage of labor

Mean duration of first stage of labor in hours

Time frame: From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours

Second stage of labour

Mean duration of second stage of labour in hours

Time frame: From cervical dilatation of 10cm until delivery of fetus

Third stage of labour

Mean duration of third stage of labour in hours

Time frame: From delivery of fetus until delivery of placenta

Blood loss

Mean blood loss in millilitres

Time frame: Through study completion up to 42 days after delivery

Mode of delivery

Percentage of participants who delivered vaginally or via caesarean section

Data from ClinicalTrials.gov

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