Prolonged LaborPhase 3NCT01854073
Hyoscine Butyl Bromide for Management of Prolonged Labor
A Phase 3 study testing Hyoscine butyl bromide and Normal saline in people with Prolonged Labor, run by Ain Shams University at 1 site in Saudi Arabia.
Trial summary
To determine the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Hyoscine butyl bromide and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2014to Jun 2017
- Phase
- Phase 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
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women.
- Prolonged labor defined as no progress of labor for 2 hours or more.
- Gestational age ≥ 37 weeks.
- Singleton pregnancy.
- Cephalic presentation.
- Cervical dilatation ≥ 5 cm.
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- Intact fetal membranes.
- No evidence of maternal or fetal distress.
- Average size baby.
Who cannot join
- Multigravid women.
- Multifetal pregnancy.
- History of cervical surgery.
- Blood pressure > 150/90 mmHg.
- Mal-presentation and mal-positions.
- Hypersensitivity to Hyoscine.
- Contraindication for vaginal delivery.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Labor and delivery ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, 'Asir Region, 101
Mohamed Kolkailah, MD, 96672500001 ext. 11232, prof.mohamed_kolkailah@hotmail.com
Mohamed I Ellaithy, MD
About this study
Official title: Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial
To determine the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term.
Read the detailed description
Management of prolonged labor represents a challenging area in the daily obstetric practice. In 1993, Handa and Laros defined the arrest of active phase of labor, as failure of labor progress for 2 hours or more, and in 1994, WHO has proposed labor management partograph in which protraction is defined as < 1cm/hour cervical dilatation for a minimum of 4 hours.
Prolong labor increase the risks of maternal exhaustion, postpartum hemorrhage, sepsis, fetal distress and admission to the neonatal intensive care unit. The treatment of prolonged labor is highly desirable goal of intrapartum care, both from prospective of maternal and fetal wellbeing and for the provider of the birth services. Management of prolonged labor entails shorter exposure to pain, anxiety, and stress, and would thus translate into a major improvement in maternal satisfaction with child birth experience.
Several methods have been used for management of prolonged labor including amniotomy and oxytocin. Amniotomy can cause infection, and can be combined with oxytocin for better results while oxytocin can cause uterine hyper stimulation, water intoxication, vomiting, diarrhea, fetal distress, and neonatal jaundice.
Use of antispasmodics for reducing the duration of labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following intrapartum administration of an antispasmodic like drug (Syntropan®), mainly among older nulliparous, this was followed by many studies that investigated the role of antispasmodics in prevention of prolonged labor, however none of the these studies assessed the value of the antispasmodic for the treatment of prolonged labor; a recent Cochrane review advised that a rigorously designed well conducted randomized controlled trial with a large sample size would be beneficial to answer the question.
Hyoscine butyl bromide is spasmolytic drug that act by competitive antagonism to acetyl choline at post ganglionic parasympathetic nerve ending. It is claimed to reduce duration of labor by accelerating cervical dilatation without major side effects. It reduces the spasm of the smooth muscles. Although the efficacy of Hyoscine has been proven in various studies there is no clear evidence to recommend their routine use in management of prolonged labor.
The objective of the current study is to determine the use of Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term, managed according to a standard intrapartum protocol.
- Conditions
- Prolonged Labor
- Being tested
- Hyoscine butyl bromide, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine butyl bromideDrug
Also called Buscopan
Normal salineDrug
Also called Sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A, will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after. Receives: Drug: Hyoscine butyl bromide |
| Group B | Placebo comparator | Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate for failure to progress
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startFeb 2014
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, Mohamed Ellaithy, Ain Shams University
- Investigators
- Mohamed Ellaithy, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854073
- Sponsor's protocol ID
- AFHSR-5-2013
- Status last verified
- Mar 2017
- First submitted
- 11 May 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01854073
- Acronym / sponsor ID
- AFHSR-5-2013
- Conditions
- Prolonged Labor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Feb 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 May 2013 (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 the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term.
Detailed description
Management of prolonged labor represents a challenging area in the daily obstetric practice. In 1993, Handa and Laros defined the arrest of active phase of labor, as failure of labor progress for 2 hours or more, and in 1994, WHO has proposed labor management partograph in which protraction is defined as < 1cm/hour cervical dilatation for a minimum of 4 hours.
Prolong labor increase the risks of maternal exhaustion, postpartum hemorrhage, sepsis, fetal distress and admission to the neonatal intensive care unit. The treatment of prolonged labor is highly desirable goal of intrapartum care, both from prospective of maternal and fetal wellbeing and for the provider of the birth services. Management of prolonged labor entails shorter exposure to pain, anxiety, and stress, and would thus translate into a major improvement in maternal satisfaction with child birth experience.
Several methods have been used for management of prolonged labor including amniotomy and oxytocin. Amniotomy can cause infection, and can be combined with oxytocin for better results while oxytocin can cause uterine hyper stimulation, water intoxication, vomiting, diarrhea, fetal distress, and neonatal jaundice.
Use of antispasmodics for reducing the duration of labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following intrapartum administration of an antispasmodic like drug (Syntropan®), mainly among older nulliparous, this was followed by many studies that investigated the role of antispasmodics in prevention of prolonged labor, however none of the these studies assessed the value of the antispasmodic for the treatment of prolonged labor; a recent Cochrane review advised that a rigorously designed well conducted randomized controlled trial with a large sample size would be beneficial to answer the question.
Hyoscine butyl bromide is spasmolytic drug that act by competitive antagonism to acetyl choline at post ganglionic parasympathetic nerve ending. It is claimed to reduce duration of labor by accelerating cervical dilatation without major side effects. It reduces the spasm of the smooth muscles. Although the efficacy of Hyoscine has been proven in various studies there is no clear evidence to recommend their routine use in management of prolonged labor.
The objective of the current study is to determine the use of Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term, managed according to a standard intrapartum protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Hyoscine butyl bromideGroup A, will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after. |
| Group B | Placebo comparator | Drug: Normal salineGroup B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Nulliparous women.
- Prolonged labor defined as no progress of labor for 2 hours or more.
- Gestational age ≥ 37 weeks.
- Singleton pregnancy.
- Cephalic presentation.
Key exclusion criteria (7 listed)
- Multigravid women.
- Multifetal pregnancy.
- History of cervical surgery.
- Blood pressure > 150/90 mmHg.
- Mal-presentation and mal-positions.
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 bromideAlso: Buscopan | Drug | Group A |
| Normal salineAlso: Sodium chloride 0.9% | Drug | Group B |
Primary outcome
Caesarean section rate for failure to progress
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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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.
Labor and delivery ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, Saudi Arabia
Mohamed Ellaithy, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyoscine butyl bromide and Normal saline in people with Prolonged Labor, run by Ain Shams University at 1 site in Saudi Arabia.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Mar 2017. 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 Saudi Arabia. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section rate for failure to progress (time frame: 6 hours). 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 10 Mar 2017.