Labor, First StagePhase 4NCT02103166
Role of Hyoscine Bromide in Latent and Active Labor
A Phase 4 study testing Hyoscine bromide and Physiological serum in people with Labor, First Stage, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, First Stage
- What is being tested?
- Hyoscine bromide and Physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Apr 2018
- Phase
- Phase 4
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 or more.
- Term pregnancy.
- Cephalic presentation.
- Oxytocin perfusion not present at the time of inclusion.
- Uterine dynamic established.
- Abscence of high risk factors or very high risk factors for pregnancy.
- Written informed consent
Who cannot join
- Induction of labor.
- Presence of risk factors.
- Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor
The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.
- Conditions
- Labor, First Stage
- Being tested
- Hyoscine bromide, Physiological serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine bromideDrug
Also called Buscapina
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
Physiological serumDrug
Also called Saline serum
100 ml of physiological serum (0.9% NaCl).
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine bromide | Experimental | 20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl). Receives: Drug: Hyoscine bromide |
| Physiological serum | Placebo comparator | 100 ml of physiological serum (0.9% NaCl). Receives: Drug: Physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete dilation
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Conditions of recruitment changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, First StageStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montse Palacio, Hospital Clinic of Barcelona
- Investigators
- Montse Palacio, MD, PhD, Principal investigator, Hospital Clinic of BarcelonaMariona Rius, MD, Study chair, Hospital Clinic of BarcelonaAna Sandra Hernandez, MD, Study chair, Hospital Clinic of BarcelonaIrene Teixido, MD, Study chair, Hospital Clinic of BarcelonaIrene Vives, MD, Study chair, Hospital Clinic of BarcelonaMidwives Collaborative Group HCP, Study chair, Hospital Clínic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103166
- Sponsor's protocol ID
- 2013-001921-19
- Status last verified
- Aug 2016
- First submitted
- 1 Apr 2014
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor
- ClinicalTrials.gov ID
- NCT02103166
- Acronym / sponsor ID
- 2013-001921-19
- Conditions
- Labor, First Stage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Conditions of recruitment changed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 3 Apr 2014 (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.
The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine bromide | Experimental | Drug: Hyoscine bromide20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl). |
| Physiological serum | Placebo comparator | Drug: Physiological serum100 ml of physiological serum (0.9% NaCl). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 or more.
- Term pregnancy.
- Cephalic presentation.
- Oxytocin perfusion not present at the time of inclusion.
- Uterine dynamic established.
Key exclusion criteria (3 listed)
- Induction of labor.
- Presence of risk factors.
- Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
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 bromideAlso: Buscapina20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl). | Drug | Hyoscine bromide |
| Physiological serumAlso: Saline serum100 ml of physiological serum (0.9% NaCl). | Drug | Physiological serum |
Primary outcome
Time to complete dilation
Time frame: One hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
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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.
Montse Palacio, MD, PhD principal investigator
Hospital Clinic of Barcelona
Mariona Rius, MD study chair
Hospital Clinic of Barcelona
Ana Sandra Hernandez, MD study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyoscine bromide and Physiological serum in people with Labor, First Stage, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 7 inclusion and 3 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: paused, as of the sponsor's last update on 19 Aug 2016. 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 Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time to complete dilation (time frame: One hour). 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 19 Aug 2016.