Labor Stage, FirstPhase 2NCT00409890
The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
A Phase 2 study testing Hyoscine Butyl Bromide in people with Labor Stage, First, run by University Hospital of the West Indies at 1 site in Jamaica.
Trial summary
To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Stage, First
- What is being tested?
- Hyoscine Butyl Bromide
- How many people
- 120 participants
- Where
- 1 siteJamaica
- Study dates
- Jun 2005to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Term pregnancy
- In spontaneous, established labour
Who cannot join
- Contraindication to vaginal delivery
- Any chronic medical or pregnancy induced illness
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.
Read the detailed description
Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals here in Jamaica, as it has elsewhere in the world. Thus, it represents a new addition to the armamentarium of active management. The mechanism by which it acts in the context of labor has not yet been elucidated, and the evidence for its efficacy was previously largely anecdotal. The specific objectives of this project are to assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor. We also intend to determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.
The study was designed as a double blind, randomized, controlled, clinical trial comparing two groups of patients matched for age and parity. One group of patients received the 20 mg(1 ml)of hyoscine butyl bromide, while the other (control) group received 1 ml of normal saline (placebo).
- Conditions
- Labor Stage, First
- Being tested
- Hyoscine Butyl Bromide
- Keywords
- Buscopan, Hyoscine, Shortens, Labor, Stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine Butyl BromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor.
Secondary outcomes (1)
To determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startJun 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Stage, FirstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University Hospital of the West Indies
- Sponsor type
- University, hospital or other
- Investigators
- Leslie A Samuels, MD, Principal investigator, University Hospital of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409890
- Sponsor's protocol ID
- ECP 109,2004/2005
- Status last verified
- Dec 2006
- First submitted
- 11 Dec 2006
- Last updated
- 12 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
- ClinicalTrials.gov ID
- NCT00409890
- Acronym / sponsor ID
- ECP 109,2004/2005
- Conditions
- Labor Stage, First
- Keywords
- Buscopan, Hyoscine, Shortens, Labor, Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- University Hospital of the West IndiesUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Oct 2005
- First posted
- 12 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.
Detailed description
Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals here in Jamaica, as it has elsewhere in the world. Thus, it represents a new addition to the armamentarium of active management. The mechanism by which it acts in the context of labor has not yet been elucidated, and the evidence for its efficacy was previously largely anecdotal. The specific objectives of this project are to assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor. We also intend to determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.
The study was designed as a double blind, randomized, controlled, clinical trial comparing two groups of patients matched for age and parity. One group of patients received the 20 mg(1 ml)of hyoscine butyl bromide, while the other (control) group received 1 ml of normal saline (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Term pregnancy
- In spontaneous, established labour
Key exclusion criteria (2 listed)
- Contraindication to vaginal delivery
- Any chronic medical or pregnancy induced illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyoscine Butyl Bromide | Drug | – |
Primary outcome
To assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor.
1 secondary outcome
To determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Samuels, MD principal investigator
University Hospital of the West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyoscine Butyl Bromide in people with Labor Stage, First, run by University Hospital of the West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2006.