Labor PainPhase 2/3NCT01644838
Effect of Hyoscine and Promethazine on Labor Pain
A Phase 2/3 study testing Hyoscine and Promethazine in people with Labor Pain, run by Mashhad University of Medical Sciences.
Trial summary
It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Hyoscine and Promethazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Apr 2011
- Phase
- Phase 2/3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 yrs,
- primiparous,
- having single fetus with cephalic presentation, gestational age 37-42 weeks,
- having no medical diseases,
- having no history of hospitalization due to psychological diseases,
- having no addiction to cigarette,
- having no complications during pregnancy such as hypertension,
- BMI< 26
Who cannot join
- bleeding
- CPD
- use of PG or Oxytocin
- fetus distress
About this study
Official title: Principal Investigator
It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. So the investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on length of active phase of the first stage of labor.
- Conditions
- Labor Pain
- Being tested
- Hyoscine, Promethazine
- Keywords
- Hyoscine,, Promethazine,, The first stage of labor,, Labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyoscineDrug
The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.
PromethazineDrug
The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.
| Study group | Role | What they receive |
|---|---|---|
| Promethazine | Experimental | 25 mg of promethazine Receives: Drug: Promethazine |
| Hyoscine | Experimental | 20 mg of hyoscine Receives: Drug: Hyoscine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Hyoscine and Promethazine on labor pain
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644838
- Sponsor's protocol ID
- Hyoscine & Promethazin
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT01644838
- Acronym / sponsor ID
- Hyoscine & Promethazin
- Conditions
- Labor Pain
- Keywords
- Hyoscine,, Promethazine,, The first stage of labor,, Labor pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Jul 2012 (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.
It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. So the investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on length of active phase of the first stage of labor.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promethazine | Experimental | Drug: Promethazine25 mg of promethazine |
| Hyoscine | Experimental | Drug: Hyoscine20 mg of hyoscine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-35 yrs,
- primiparous,
- having single fetus with cephalic presentation, gestational age 37-42 weeks,
- having no medical diseases,
- having no history of hospitalization due to psychological diseases,
Key exclusion criteria (4 listed)
- bleeding
- CPD
- use of PG or Oxytocin
- fetus distress
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 |
|---|---|---|
| HyoscineThe samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm. | Drug | Hyoscine |
| PromethazineThe samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm. | Drug | Promethazine |
Primary outcome
Effect of Hyoscine and Promethazine on labor pain
Time frame: up to 9 months
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 20 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyoscine and Promethazine in people with Labor Pain, run by Mashhad University of Medical Sciences.
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 8 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 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Effect of Hyoscine and Promethazine on labor pain (time frame: up to 9 months). 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 20 Jul 2012.