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

April 4, 2022 updated by: Rahana Abd Rahman, National University of Malaysia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Labor length
Time Frame: Through study completion until delivery up to 12 hours
Duration of labor
Through study completion until delivery up to 12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal age
Time Frame: At the time of recruitment
Mean maternal age in years
At the time of recruitment
Gestational age
Time Frame: At the time of recruitment
Mean gestational age in weeks
At the time of recruitment
Pre-pregnancy body mass index
Time Frame: At the time of recruitment
Mean body mass index in kg/m2
At the time of recruitment
First stage of labor
Time Frame: From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours
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
Time Frame: From cervical dilatation of 10cm until delivery of fetus
Mean duration of second stage of labour in hours
From cervical dilatation of 10cm until delivery of fetus
Third stage of labour
Time Frame: From delivery of fetus until delivery of placenta
Mean duration of third stage of labour in hours
From delivery of fetus until delivery of placenta
Blood loss
Time Frame: Through study completion up to 42 days after delivery
Mean blood loss in millilitres
Through study completion up to 42 days after delivery
Mode of delivery
Time Frame: Through study completion up to 12 hours
Percentage of participants who delivered vaginally or via caesarean section
Through study completion up to 12 hours
Analgesia
Time Frame: Through study completion until delivery up to 12 hours
Percentage of women need analgesia
Through study completion until delivery up to 12 hours
Pain score
Time Frame: Pre-intervention
Mean pain score
Pre-intervention
Pain score 2 hours
Time Frame: From time of intervention up to 2 hours after
Mean pain score at 2 hours
From time of intervention up to 2 hours after
Pain score 4 hours
Time Frame: From time of intervention up to 4 hours after
Mean pain score at 4 hours
From time of intervention up to 4 hours after
Pain score 6 hours
Time Frame: From time of intervention up to 6 hours after
Mean pain score at 6 hours
From time of intervention up to 6 hours after
Neonatal outcome 1 minute
Time Frame: From delivery of neonate up to 1 minute after
Mean apgar score at 1 minute
From delivery of neonate up to 1 minute after
Neonatal outcome 5 minute
Time Frame: From delivery of neonate up to 5 minutes after
Mean apgar score at 1 minute
From delivery of neonate up to 5 minutes after
Neonatal intensive care unit admission
Time Frame: From delivery of neonate up to 30 days
Percentage of neonates require admission to neonatal intensive care unit admission
From delivery of neonate up to 30 days
Side effects
Time Frame: Through study completion up to 42 days after delivery
Percentage of participants who develop side effects to treatment
Through study completion up to 42 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aida Hani Mohd Kalok, National University Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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