BUSCLAB - Buscopan to Prevent Slow Progress in Labor

December 18, 2022 updated by: Trond Melbye Michelsen, Oslo University Hospital

BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor

To study the effect of Butylscopolamine Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph.

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.

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.
250

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 3

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

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital Rikshospitalet

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:

  • ≥18 years
  • Primiparous women
  • Spontaneous onset of labor
  • Active phase of labor
  • ≥37 weeks of gestation
  • Vertex position
  • Crossing the alert line, i.e. cervical dilatation of less than one cm per hour in the active phase of first stage of labour (cervix dilation ≥3 - <10 cm)
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national and local regulations

Exclusion Criteria:

  • Multiple gestation
  • Elective cesarean section
  • Women in labor already receiving oxytocin when crossing the alert line
  • Fully dilated cervix when crossing the alert line
  • Preeclampsia defined as blood pressure ≥140/90 and proteinuria (1 or more on a urine dipstick on more than one occasion) with debut after 20 weeks of pregnancy
  • Known intestinal stenosis, ileus or megacolon
  • Persisting maternal tachycardia (heart rate >130 beats per minute)
  • Known maternal myasthenia gravis
  • Persisting fetal tachycardia (fetal heart rate baseline >170 beats per minute)
  • Hypersensitivity to any of the ingredients in IMP or placebo (butylscopolamine bromide or sodium chloride)
  • Women with heart disease who are under surveillance with heart rate monitoring during labor
  • Known fetal heart disease
  • Untreated glaucoma

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: Triple

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.
Experimental: Treatment arm
1mL 20 mg/mL butylscopolamine bromide i.v.
Drug: Butylscopolamine Bromide 20 MG/ML
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
Placebo Comparator: Placebo
1mL 9mg/mL NaCl
Drug: Sodium Chloride 9mg/mL
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.

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
Duration of labor from the time when the participant was given IMP to delivery
Time Frame: Up to 24 hours
Time to event variable
Up to 24 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
Duration from when the participant was given IMP, to 10 cm dilatation
Time Frame: Up to 24 hours
Time to event variable
Up to 24 hours
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm
Time Frame: Up to 24 hours
Continuous variable
Up to 24 hours
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Time Frame: Up to 24 hours
Time to event variable
Up to 24 hours
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)
Time Frame: At birth
Categorical variable, fraction of all deliveries
At birth
Vaginal delivery vs cesarean delivery
Time Frame: At birth
Categorical variable, fraction of all deliveries
At birth
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Time Frame: At birth
Categorical variable, fraction of all deliveries
At birth
Amount of oxytocin given, measured 1. As total time with treatment
Time Frame: Up to 24 hours
Continuous variable, minutes
Up to 24 hours
Amount of oxytocin given, measured 2. As International Units (IU)
Time Frame: At birth
Continuous variable
At birth
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP
Time Frame: up to 30 minutes
Continuous variable, scale 1 to 9, where 9 is most severe pain
up to 30 minutes
Postpartum hemorrhage (mL)
Time Frame: 2 hours after birth
Continuous variable
2 hours after birth
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward
Time Frame: 24 hours after birth
Categorical variable, fraction of women with urinary retention
24 hours after birth
Anal sphincter injury
Time Frame: At birth
Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries
At birth
Apgar score at 5 minutes and 10 minutes after delivery
Time Frame: 5 and 10 minutes after birth
Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate
5 and 10 minutes after birth
pH levels in umbilical vein and artery after delivery
Time Frame: At birth
Continuous variable
At birth
Admission to the Neonatal Intensive Care Unit
Time Frame: Within 2 hours after birth
Categorical variable, fraction of deliveries
Within 2 hours after birth
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
Time Frame: 4 weeks after birth
Continuous variable for each category
4 weeks after birth

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.
Oslo University Hospital

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: Trond M Michelsen, MD, PhD, Oslo University Hospital

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.
May 25, 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.
August 29, 2021

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 16, 2022

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).
May 22, 2019

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.
May 22, 2019

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.
May 23, 2019

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.
December 20, 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.
December 18, 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.
December 1, 2022

More Information

Terms related to this study

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.
  • 2018/2380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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