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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-06-30

Brief Summary

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

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Detailed Description

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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)

Conditions

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Labor Long

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between participants who receive hyoscine and those who do not.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants and care provider are blinded from the treatment

Study Groups

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Hyoscine

Participants receive intravenous bolus of 1ml (20 mg) Hyoscine

Group Type ACTIVE_COMPARATOR

Hyoscine Butylbromide

Intervention Type DRUG

Intervention is given once a participant is in established labor

Placebo

Participants receive intravenous bolus of 1ml normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intervention is given once a participant is in established labor

Interventions

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Hyoscine Butylbromide

Intervention is given once a participant is in established labor

Intervention Type DRUG

Placebo

Intervention is given once a participant is in established labor

Intervention Type OTHER

Other Intervention Names

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Buscopan

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes