Labor ComplicationPhase 3SAINTNCT05719467
SAINT: Safe Induction of Labor Trial
A Phase 3 study testing Buscopan 20 MG/ML Injectable Solution, Sodium bicarbonate and Nacl 0.9% in people with Labor Complication and Induced; Birth, run by Oslo University Hospital at 5 sites in Norway.
Trial summary
Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication, Induced; Birth, Pregnancy Related
- What is being tested?
- Buscopan 20 MG/ML Injectable Solution, Sodium bicarbonate and Nacl 0.9%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 5 sitesNorway
- Study dates
- 3 Jan 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be between 18 and 50 years of age at the time of signing the informed consent.
- Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation
- Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made
- Participants carrying a fetus in vertex position
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Who cannot join
- Multiple gestation
- Elective cesarean section
- Spontaneous start of labor
- Known maternal intestinal stenosis, ileus or megacolon
- Persisting maternal tachycardia (heart rate > 130 beats per minute) >30 minutes continuously.
- Known maternal myasthenia gravis
Show all 15Show fewer
- Persisting fetal tachycardia (fetal heart rate baseline > 170 beats per minute) >30 minutes continuously.
- Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride)
- Women with heart disease who are under surveillance with heart rate monitoring during labor
- Known fetal heart disease or known fetal malformations in the gastrointestinal system
- Untreated maternal glaucoma
- Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia
- Maternal moderate/severe kidney failure (stage III-V: glomerulus filtration rate <59 ml/minute/1.73m2 )
- Maternal elevated serum creatinine (>90umol/L)
- Maternal elevated Alanine Aminotransferase (ALAT) >100 U/L. Participation can still be considered for participants with ALAT >100 U/L if explained by obstetric cholestasis or HELLP syndrome.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Norway5 sites, 5 recruiting
- Recruiting
Akershus University Hospital
Lørenskog
Camilla Haavaldsen, MD, PhD
- Recruiting
Oslo University Hospital Rikshospitalet
Oslo, 0424
Trond M Michelsen, MD, PhD, +472307000, trmi1@ous-hf.no
Ingvil K Sorbye, MD, PhD, +4723072640, isorbye@ous-hf.no
- Recruiting
Oslo University Hospital Ullevål
Oslo
Anne F Jacobsen, MD, PhD, uxafja@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger
Ragnar K Sande, MD, PhD
- Recruiting
The University Hospital of North Norway
Tromsø
Åse T Pettersen, MD
About this study
Official title: A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor
Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.
At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.
Read more
Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.
Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.
The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.
- Conditions
- Labor Complication, Induced; Birth, Pregnancy Related
- Being tested
- Buscopan 20 MG/ML Injectable Solution, Sodium bicarbonate, Placebo, Nacl 0.9%
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buscopan 20 MG/ML Injectable SolutionDrug
1 mL intravenously
Sodium bicarbonateDrug
4 g orally
PlaceboDrug
Also called Oral Tab
4g orally
Nacl 0.9%Drug
Also called Intravenous placebo
1 mL intravenously
| Study group | Role | What they receive |
|---|---|---|
| Buscopan and bicarbonate | Active comparator | Not described Receives: Drug: Buscopan 20 MG/ML Injectable Solution; Drug: Sodium bicarbonate |
| Buscopan and placebo | Active comparator | Not described Receives: Drug: Buscopan 20 MG/ML Injectable Solution; Drug: Placebo |
| Placebo and bicarbonate | Active comparator | Not described Receives: Drug: Sodium bicarbonate; Drug: Nacl 0.9% |
| Placebo and placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Nacl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous vs operative birth
Number of participants with operative birth as compared to spontaneous birth
Measured: Through study completion, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start3 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
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 ComplicationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
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
- NCT05719467
- Sponsor's protocol ID
- 235247
- Acronym
- SAINT
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sorbye IK, Gunnes N, Solhoff AV, Haavaldsen C, Kessler J, Kjollesdal AM, Jacobsen AF, Magnussen EB, Pettersen ATR, Sande RK, Sjoborg KD, Ween-Velken ME, Leeves LT, Michelsen TM; SAINT Consortium. Multicentre double-blind randomised placebo-controlled four-arm trial to assess the effect of oral sodium bicarbonate and intravenous hyoscine butylbromide on spontaneous delivery after induction of labour in nulliparous women: protocol for the Safe Induction of Labour Trial (SAINT). BMJ Open. 2025 Mar 3;15(3):e093992. doi: 10.1136/bmjopen-2024-093992.
PubMed 40032397
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor
- ClinicalTrials.gov ID
- NCT05719467
- Acronym / sponsor ID
- SAINT / 235247
- Conditions
- Labor Complication, Induced; Birth, Pregnancy Related
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2023 (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.
Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.
At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.
Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.
Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.
The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buscopan and bicarbonate | Active comparator | Drug: Buscopan 20 MG/ML Injectable Solution, Drug: Sodium bicarbonate |
| Buscopan and placebo | Active comparator | Drug: Buscopan 20 MG/ML Injectable Solution, Drug: Placebo |
| Placebo and bicarbonate | Active comparator | Drug: Sodium bicarbonate, Drug: Nacl 0.9% |
| Placebo and placebo | Placebo comparator | Drug: Placebo, Drug: Nacl 0.9% |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be between 18 and 50 years of age at the time of signing the informed consent.
- Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation
- Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made
- Participants carrying a fetus in vertex position
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Key exclusion criteria (15 listed)
- Multiple gestation
- Elective cesarean section
- Spontaneous start of labor
- Known maternal intestinal stenosis, ileus or megacolon
- Persisting maternal tachycardia (heart rate > 130 beats per minute) >30 minutes continuously.
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 |
|---|---|---|
| Buscopan 20 MG/ML Injectable Solution1 mL intravenously | Drug | Buscopan and bicarbonate, Buscopan and placebo |
| Sodium bicarbonate4 g orally | Drug | Buscopan and bicarbonate, Placebo and bicarbonate |
| PlaceboAlso: Oral Tab4g orally | Drug | Buscopan and placebo, Placebo and placebo |
| Nacl 0.9%Also: Intravenous placebo1 mL intravenously | Drug | Placebo and bicarbonate, Placebo and placebo |
Primary outcome
Spontaneous vs operative birth
Time frame: Through study completion, an average of one week
Number of participants with operative birth as compared to spontaneous birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 40032397Sorbye IK, Gunnes N, Solhoff AV, Haavaldsen C, Kessler J, Kjollesdal AM, Jacobsen AF, Magnussen EB, Pettersen ATR, Sande RK, Sjoborg KD, Ween-Velken ME, Leeves LT, Michelsen TM; SAINT Consortium. Multicentre double-blind randomised placebo-controlled four-arm trial to assess the effect of oral sodium bicarbonate and intravenous hyoscine butylbromide on spontaneous delivery after induction of labour in nulliparous women: protocol for the Safe Induction of Labour Trial (SAINT). BMJ Open. 2025 Mar 3;15(3):e093992. doi: 10.1136/bmjopen-2024-093992.
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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.
Trond M Michelsen, MD PhD principal investigator
Oslo University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buscopan 20 MG/ML Injectable Solution, Sodium bicarbonate and Nacl 0.9% in people with Labor Complication and Induced; Birth, run by Oslo University Hospital at 5 sites 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trond M Michelsen, MD PhD (+4723070000, trmi1@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous vs operative birth (time frame: Through study completion, an average of one week). 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 NCT05719467, 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 4 Apr 2024.