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

Labor Long Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349722
• Other study ID #: FF-2019-521
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor Long

Intervention

Drug:
• Hyoscine Butylbromide
Intervention is given once a participant is in established labor

Other:
• Placebo
Intervention is given once a participant is in established labor

Locations

Country	Name	City	State
Malaysia	National University Malaysia Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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