Labor (Obstetrics)--ComplicationsPhase 3NCT03961165
BUSCLAB - Buscopan to Prevent Slow Progress in Labor
A Phase 3 study testing Butylscopolamine Bromide 20 MG/ML and Sodium Chloride 9mg/mL in people with Labor (Obstetrics)--Complications and Labor; Prolonged, First Stage, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To study the effect of Butylscopolamine Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph. 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 (Obstetrics)--Complications, Labor; Prolonged, First Stage
- What is being tested?
- Butylscopolamine Bromide 20 MG/ML and Sodium Chloride 9mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 25 May 2019to 16 Jun 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years
- Primiparous women
- Spontaneous onset of labor
- Active phase of labor
- ≥37 weeks of gestation
- Vertex position
- Crossing the alert line, i.e. cervical dilatation of less than one cm per hour in the active phase of first stage of labour (cervix dilation ≥3 - <10 cm)
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national and local regulations
Who cannot join
- Multiple gestation
- Elective cesarean section
- Women in labor already receiving oxytocin when crossing the alert line
- Fully dilated cervix when crossing the alert line
- Preeclampsia defined as blood pressure ≥140/90 and proteinuria (1 or more on a urine dipstick on more than one occasion) with debut after 20 weeks of pregnancy
- Known intestinal stenosis, ileus or megacolon
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- Persisting maternal tachycardia (heart rate >130 beats per minute)
- Known maternal myasthenia gravis
- Persisting fetal tachycardia (fetal heart rate baseline >170 beats per minute)
- Hypersensitivity to any of the ingredients in IMP or placebo (butylscopolamine bromide or sodium chloride)
- Women with heart disease who are under surveillance with heart rate monitoring during labor
- Known fetal heart disease
- Untreated glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor
To study the effect of Butylscopolamine Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph.
- Being tested
- Butylscopolamine Bromide 20 MG/ML, Sodium Chloride 9mg/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butylscopolamine Bromide 20 MG/MLDrug
1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
Sodium Chloride 9mg/mLDrug
1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 1mL 20 mg/mL butylscopolamine bromide i.v. Receives: Drug: Butylscopolamine Bromide 20 MG/ML |
| Placebo | Placebo comparator | 1mL 9mg/mL NaCl Receives: Drug: Sodium Chloride 9mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labor from the time when the participant was given IMP to delivery
Time to event variable
Measured: Up to 24 hours
Secondary outcomes (16)
Duration from when the participant was given IMP, to 10 cm dilatation
Time to event variable
Measured: Up to 24 hours
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm
Continuous variable
Measured: Up to 24 hours
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Time to event variable
Measured: Up to 24 hours
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)
Categorical variable, fraction of all deliveries
Measured: At birth
Vaginal delivery vs cesarean delivery
Categorical variable, fraction of all deliveries
Measured: At birth
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Categorical variable, fraction of all deliveries
Measured: At birth
Amount of oxytocin given, measured 1. As total time with treatment
Continuous variable, minutes
Measured: Up to 24 hours
Amount of oxytocin given, measured 2. As International Units (IU)
Continuous variable
Measured: At birth
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP
Continuous variable, scale 1 to 9, where 9 is most severe pain
Measured: up to 30 minutes
Postpartum hemorrhage (mL)
Continuous variable
Measured: 2 hours after birth
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward
Categorical variable, fraction of women with urinary retention
Measured: 24 hours after birth
Anal sphincter injury
Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries
Measured: At birth
Apgar score at 5 minutes and 10 minutes after delivery
Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate
Measured: 5 and 10 minutes after birth
pH levels in umbilical vein and artery after delivery
Continuous variable
Measured: At birth
Admission to the Neonatal Intensive Care Unit
Categorical variable, fraction of deliveries
Measured: Within 2 hours after birth
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
Continuous variable for each category
Measured: 4 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start25 May 2019
- Primary completion29 Aug 2021
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor (Obstetrics)--ComplicationsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trond Melbye Michelsen, Oslo University Hospital
- Investigators
- Trond M Michelsen, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961165
- Sponsor's protocol ID
- 2018/2380
- Status last verified
- Dec 2022
- First submitted
- 22 May 2019
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaudernack LC, Einarsen AES, Sorbye IK, Lukasse M, Gunnes N, Michelsen TM. The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial. PLoS Med. 2024 Mar 28;21(3):e1004352. doi: 10.1371/journal.pmed.1004352. eCollection 2024 Mar.
PubMed 38547322
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor
- ClinicalTrials.gov ID
- NCT03961165
- Acronym / sponsor ID
- 2018/2380
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 23 May 2019 (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 study the effect of Butylscopolamine Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Butylscopolamine Bromide 20 MG/ML1mL 20 mg/mL butylscopolamine bromide i.v. |
| Placebo | Placebo comparator | Drug: Sodium Chloride 9mg/mL1mL 9mg/mL NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years
- Primiparous women
- Spontaneous onset of labor
- Active phase of labor
- ≥37 weeks of gestation
Key exclusion criteria (13 listed)
- Multiple gestation
- Elective cesarean section
- Women in labor already receiving oxytocin when crossing the alert line
- Fully dilated cervix when crossing the alert line
- Preeclampsia defined as blood pressure ≥140/90 and proteinuria (1 or more on a urine dipstick on more than one occasion) with debut after 20 weeks of pregnancy
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 |
|---|---|---|
| Butylscopolamine Bromide 20 MG/ML1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose. | Drug | Treatment arm |
| Sodium Chloride 9mg/mL1 mL Sodium Chloride 9 mg/mL i.v. Single dose. | Drug | Placebo |
Primary outcome
Duration of labor from the time when the participant was given IMP to delivery
Time frame: Up to 24 hours
Time to event variable
16 secondary outcomes
Duration from when the participant was given IMP, to 10 cm dilatation
Time frame: Up to 24 hours
Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm
Time frame: Up to 24 hours
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Time frame: Up to 24 hours
Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery)
Time frame: At birth
Vaginal delivery vs cesarean delivery
Time frame: At birth
Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Time frame: At birth
Amount of oxytocin given, measured 1. As total time with treatment
Time frame: Up to 24 hours
Amount of oxytocin given, measured 2. As International Units (IU)
Time frame: At birth
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP
Time frame: up to 30 minutes
Postpartum hemorrhage (mL)
Time frame: 2 hours after birth
Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward
Time frame: 24 hours after birth
Anal sphincter injury
Time frame: At birth
Apgar score at 5 minutes and 10 minutes after delivery
Time frame: 5 and 10 minutes after birth
pH levels in umbilical vein and artery after delivery
Time frame: At birth
Admission to the Neonatal Intensive Care Unit
Time frame: Within 2 hours after birth
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
Time frame: 4 weeks after birth
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 Dec 2022.
- Derived from this study: PubMed 38547322Gaudernack LC, Einarsen AES, Sorbye IK, Lukasse M, Gunnes N, Michelsen TM. The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial. PLoS Med. 2024 Mar 28;21(3):e1004352. doi: 10.1371/journal.pmed.1004352. eCollection 2024 Mar.
- 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.
Trond M Michelsen, MD, PhD principal investigator
Oslo University Hospital
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 Butylscopolamine Bromide 20 MG/ML and Sodium Chloride 9mg/mL in people with Labor (Obstetrics)--Complications and Labor; Prolonged, First Stage, run by Oslo University Hospital at 1 site in Norway.
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 13 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 Dec 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 Norway. 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?
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 labor from the time when the participant was given IMP to delivery (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03961165, which also lists 1 linked publication.
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 Dec 2022.