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

A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

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

Study Overview

• Status: Completed
• Conditions: Labor Long
• Intervention / Treatment: Drug: Hyoscine Butylbromide; Other: Placebo

Detailed Description

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
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • National University Malaysia Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyoscine; Participants receive intravenous bolus of 1ml (20 mg) Hyoscine	Drug: Hyoscine Butylbromide; Intervention is given once a participant is in established labor; Other Names: Buscopan
Placebo Comparator: Placebo; Participants receive intravenous bolus of 1ml normal saline	Other: Placebo; Intervention is given once a participant is in established labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor length	Duration of labor	Through study completion until delivery up to 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal age	Mean maternal age in years	At the time of recruitment
Gestational age	Mean gestational age in weeks	At the time of recruitment
Pre-pregnancy body mass index	Mean body mass index in kg/m2	At the time of recruitment
First stage of labor	Mean duration of first stage of labor in hours	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	From cervical dilatation of 10cm until delivery of fetus
Third stage of labour	Mean duration of third stage of labour in hours	From delivery of fetus until delivery of placenta
Blood loss	Mean blood loss in millilitres	Through study completion up to 42 days after delivery
Mode of delivery	Percentage of participants who delivered vaginally or via caesarean section	Through study completion up to 12 hours
Analgesia	Percentage of women need analgesia	Through study completion until delivery up to 12 hours
Pain score	Mean pain score	Pre-intervention
Pain score 2 hours	Mean pain score at 2 hours	From time of intervention up to 2 hours after
Pain score 4 hours	Mean pain score at 4 hours	From time of intervention up to 4 hours after
Pain score 6 hours	Mean pain score at 6 hours	From time of intervention up to 6 hours after
Neonatal outcome 1 minute	Mean apgar score at 1 minute	From delivery of neonate up to 1 minute after
Neonatal outcome 5 minute	Mean apgar score at 1 minute	From delivery of neonate up to 5 minutes after
Neonatal intensive care unit admission	Percentage of neonates require admission to neonatal intensive care unit admission	From delivery of neonate up to 30 days
Side effects	Percentage of participants who develop side effects to treatment	Through study completion up to 42 days after delivery

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Aida Hani Mohd Kalok, National University Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Duration of labour; hyoscine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: FF-2019-521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No