SAINT: Safe Induction of Labor Trial

NCT05719467 | Recruiting Phase 3 DMC

• 1 other identifier: 235247
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Labor Complication; Induced; Birth; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Spontaneous vs operative birth

  Number of participants with operative birth as compared to spontaneous birth

  Through study completion, an average of one week

Study Arms (4)

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%

Interventions

Buscopan 20 MG/ML Injectable Solution DRUG

1 mL intravenously

Buscopan and bicarbonate; Buscopan and placebo

Sodium bicarbonate DRUG

4 g orally

Buscopan and bicarbonate; Placebo and bicarbonate

Placebo DRUG

4g orally

Also known as: Oral Tab

Buscopan and placebo; Placebo and placebo

Nacl 0.9% DRUG

1 mL intravenously

Also known as: Intravenous placebo

Placebo and bicarbonate; Placebo and placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (5)

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

RECRUITING

Oslo University Hospital Ullevål

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

The University Hospital of North Norway

Tromsø, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 40032397 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Butylscopolammonium Bromide; Sodium Bicarbonate; Tablets; Sodium Chloride

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Dosage Forms; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Trond M Michelsen, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trond M Michelsen, MD PhD

CONTACT

+4723070000; trmi1@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: February 9, 2023
• Study Start: January 3, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

NO (5)