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

NCT04349722 | Completed Phase 4

• 1 other identifier: FF-2019-521
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor Long

Keywords

hyoscine; Duration of labour

Outcome Measures

Primary Outcomes (1)

• Labor length

  Duration of labor

  Through study completion until delivery up to 12 hours

Secondary Outcomes (17)

• Maternal age

  At the time of recruitment

• Gestational age

  At the time of recruitment

• Pre-pregnancy body mass index

  At the time of recruitment

• First stage of labor

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

• Second stage of labour

  From cervical dilatation of 10cm until delivery of fetus

Study Arms (2)

Hyoscine

ACTIVE COMPARATOR

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

Drug: Hyoscine Butylbromide

Placebo

PLACEBO COMPARATOR

Participants receive intravenous bolus of 1ml normal saline

Other: Placebo

Interventions

Hyoscine Butylbromide DRUG

Intervention is given once a participant is in established labor

Also known as: Buscopan

Hyoscine

Placebo OTHER

Intervention is given once a participant is in established labor

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Aida Hani Mohd Kalok

  National University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and care provider are blinded from the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-primary investigator

Model Details: Comparison between participants who receive hyoscine and those who do not.

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 16, 2020
• Study Start: December 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

MY (1)