LaborNCT03441217
Hyoscine Butylbromide Effect on Duration of Labor
A study testing Hyoscine Butylbromide 20Mg/1mL Injection and Saline Solution in people with Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor
- What is being tested?
- Hyoscine Butylbromide 20Mg/1mL Injection and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 sitePanama
- Study dates
- 12 Jul 2019to 30 Nov 2019
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Low risk gestation between 37 and 41 6/7 weeks.
- Cephalic (vertex) presentation.
- Spontaneous labor in active phase (4 cms)
Who cannot join
- Premature rupture of membranes upon arrival at the Labor and Delivery Unit > 4 hours.
- Multiple order pregnancy.
- Stillbirth.
- Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial
To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.
- Conditions
- Labor
- Being tested
- Hyoscine Butylbromide 20Mg/1mL Injection, Saline Solution
- Keywords
- Duration of labor, Hyoscine butylbromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine Butylbromide 20Mg/1mL InjectionDrug
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).
Saline SolutionDrug
Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine Butylbromide 20Mg/1mL Injection | Experimental | Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms). Receives: Drug: Hyoscine Butylbromide 20Mg/1mL Injection |
| Saline solution | Placebo comparator | Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms). Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of first stage of labor
Time measured from the moment the patient receive the allocated medication/placebo to complete dilation
Measured: 24 hours
Rate of cervical dilation
Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation
Measured: 24 hours
Secondary outcomes (2)
Duration of labor
Time measured from the moment the patient receive the allocated medication/placebo to delivery
Measured: 24 hours
Fetal and neonatal complications
Number of adverse events (fetal or neonatal)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start12 Jul 2019
- Primary completion30 Aug 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Collaborators
- Sistema Nacional de Investigadores de Panamá
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Study director, Maternidad del Hospital Santo Tomás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441217
- Sponsor's protocol ID
- MHST2014-05
- Status last verified
- Dec 2019
- First submitted
- 13 Feb 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03441217
- Acronym / sponsor ID
- MHST2014-05
- Conditions
- Labor
- Keywords
- Duration of labor, Hyoscine butylbromide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Collaborators
- Sistema Nacional de Investigadores de Panamá
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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 evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine Butylbromide 20Mg/1mL Injection | Experimental | Drug: Hyoscine Butylbromide 20Mg/1mL InjectionNulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms). |
| Saline solution | Placebo comparator | Drug: Saline SolutionNulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Low risk gestation between 37 and 41 6/7 weeks.
- Cephalic (vertex) presentation.
- Spontaneous labor in active phase (4 cms)
Key exclusion criteria (4 listed)
- Premature rupture of membranes upon arrival at the Labor and Delivery Unit > 4 hours.
- Multiple order pregnancy.
- Stillbirth.
- Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
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 Butylbromide 20Mg/1mL InjectionNulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms). | Drug | Hyoscine Butylbromide 20Mg/1mL Injection |
| Saline SolutionNulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms). | Drug | Saline solution |
Primary outcome
Duration of first stage of labor
Time frame: 24 hours
Time measured from the moment the patient receive the allocated medication/placebo to complete dilation
Rate of cervical dilation
Time frame: 24 hours
Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation
2 secondary outcomes
Duration of labor
Time frame: 24 hours
Fetal and neonatal complications
Time frame: 72 hours
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 6 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Osvaldo Reyes, MD study director
Maternidad del Hospital Santo Tomás
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyoscine Butylbromide 20Mg/1mL Injection and Saline Solution in people with Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 4 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 6 Dec 2019. 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 Panama. 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.
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?
Duration of first stage of labor (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 6 Dec 2019.