Labor LongPhase 4NCT04349722
The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
A Phase 4 study testing Hyoscine Butylbromide in people with Labor Long, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study compares the duration of active phase of labour in women who received buscopan and those who don't. 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 Long
- What is being tested?
- Hyoscine Butylbromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2019to 30 Jun 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primigravida
- Vertex presentation
- Term gestation (37-41w)
- Active phase of labor (4cm with regular contraction at least 2:10)
- Spontaneous labor
- Oxytocin augmentation
- Maternal height ≥150cm
Who cannot join
- Multiple pregnancies
- Previous uterine surgery
- Hypertensive disease in pregnancy
- Gestational diabetes on treatment
- Clinical estimation of fetal weight >3.8kg
- Induction of labor
Show all 9Show fewer
- Meconium stained liquor
- Allergy to hyoscine
- Medical contraindication to hyoscine (i.e Myasthenia gravis, glaucoma, megacolon)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000
About this study
Official title: A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
This study compares the duration of active phase of labour in women who received buscopan and those who don't.
Read the detailed description
A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)
- Conditions
- Labor Long
- Being tested
- Hyoscine Butylbromide, Placebo
- Keywords
- hyoscine, Duration of labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine ButylbromideDrug
Also called Buscopan
Intervention is given once a participant is in established labor
PlaceboOther
Intervention is given once a participant is in established labor
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine | Active comparator | Participants receive intravenous bolus of 1ml (20 mg) Hyoscine Receives: Drug: Hyoscine Butylbromide |
| Placebo | Placebo comparator | Participants receive intravenous bolus of 1ml normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor length
Duration of labor
Measured: Through study completion until delivery up to 12 hours
Secondary outcomes (17)
Maternal age
Mean maternal age in years
Measured: At the time of recruitment
Gestational age
Mean gestational age in weeks
Measured: At the time of recruitment
Pre-pregnancy body mass index
Mean body mass index in kg/m2
Measured: At the time of recruitment
First stage of labor
Mean duration of first stage of labor in hours
Measured: From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours
Second stage of labour
Mean duration of second stage of labour in hours
Measured: From cervical dilatation of 10cm until delivery of fetus
Third stage of labour
Mean duration of third stage of labour in hours
Measured: From delivery of fetus until delivery of placenta
Blood loss
Mean blood loss in millilitres
Measured: Through study completion up to 42 days after delivery
Mode of delivery
Percentage of participants who delivered vaginally or via caesarean section
Measured: Through study completion up to 12 hours
Analgesia
Percentage of women need analgesia
Measured: Through study completion until delivery up to 12 hours
Pain score
Mean pain score
Measured: Pre-intervention
Pain score 2 hours
Mean pain score at 2 hours
Measured: From time of intervention up to 2 hours after
Pain score 4 hours
Mean pain score at 4 hours
Measured: From time of intervention up to 4 hours after
Pain score 6 hours
Mean pain score at 6 hours
Measured: From time of intervention up to 6 hours after
Neonatal outcome 1 minute
Mean apgar score at 1 minute
Measured: From delivery of neonate up to 1 minute after
Neonatal outcome 5 minute
Mean apgar score at 1 minute
Measured: From delivery of neonate up to 5 minutes after
Neonatal intensive care unit admission
Percentage of neonates require admission to neonatal intensive care unit admission
Measured: From delivery of neonate up to 30 days
Side effects
Percentage of participants who develop side effects to treatment
Measured: Through study completion up to 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor LongStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between participants who receive hyoscine and those who do not.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
- Investigators
- Aida Hani Mohd Kalok, Principal investigator, National University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349722
- Sponsor's protocol ID
- FF-2019-521
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
- ClinicalTrials.gov ID
- NCT04349722
- Acronym / sponsor ID
- FF-2019-521
- Conditions
- Labor Long
- Keywords
- hyoscine, Duration of labour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Apr 2020 (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.
This study compares the duration of active phase of labour in women who received buscopan and those who don't.
Detailed description
A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Comparison between participants who receive hyoscine and those who do not.
| Arm | Type | Receives |
|---|---|---|
| Hyoscine | Active comparator | Drug: Hyoscine ButylbromideParticipants receive intravenous bolus of 1ml (20 mg) Hyoscine |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive intravenous bolus of 1ml normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primigravida
- Vertex presentation
- Term gestation (37-41w)
- Active phase of labor (4cm with regular contraction at least 2:10)
- Spontaneous labor
Key exclusion criteria (9 listed)
- Multiple pregnancies
- Previous uterine surgery
- Hypertensive disease in pregnancy
- Gestational diabetes on treatment
- Clinical estimation of fetal weight >3.8kg
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 ButylbromideAlso: BuscopanIntervention is given once a participant is in established labor | Drug | Hyoscine |
| PlaceboIntervention is given once a participant is in established labor | Other | Placebo |
Primary outcome
Labor length
Time frame: Through study completion until delivery up to 12 hours
Duration of labor
17 secondary outcomes
Maternal age
Time frame: At the time of recruitment
Gestational age
Time frame: At the time of recruitment
Pre-pregnancy body mass index
Time frame: At the time of recruitment
First stage of labor
Time frame: From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours
Second stage of labour
Time frame: From cervical dilatation of 10cm until delivery of fetus
Third stage of labour
Time frame: From delivery of fetus until delivery of placenta
Blood loss
Time frame: Through study completion up to 42 days after delivery
Mode of delivery
Time frame: Through study completion up to 12 hours
Analgesia
Time frame: Through study completion until delivery up to 12 hours
Pain score
Time frame: Pre-intervention
Pain score 2 hours
Time frame: From time of intervention up to 2 hours after
Pain score 4 hours
Time frame: From time of intervention up to 4 hours after
Pain score 6 hours
Time frame: From time of intervention up to 6 hours after
Neonatal outcome 1 minute
Time frame: From delivery of neonate up to 1 minute after
Neonatal outcome 5 minute
Time frame: From delivery of neonate up to 5 minutes after
Neonatal intensive care unit admission
Time frame: From delivery of neonate up to 30 days
Side effects
Time frame: Through study completion up to 42 days after delivery
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 Apr 2022.
Related trials for Labor Long
RecruitingPhase 3
A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works
Paroxysmal Nocturnal Hemoglobinuria
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingPhase 3
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Ulcerative Colitis
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
Not yet recruitingObservational study
eCPAP Follow-up at School Age
Lung Function
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.
Aida Hani Mohd Kalok principal investigator
National University Malaysia
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 Butylbromide in people with Labor Long, run by National University of Malaysia at 1 site in Malaysia.
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 9 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 Apr 2022. 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 Malaysia. 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?
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?
Labor length (time frame: Through study completion until delivery up to 12 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 6 Apr 2022.