NCT05719467 SAINT: Safe Induction of Labor Trial
| NCT ID | NCT05719467 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Oslo University Hospital |
| Condition | Labor Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-01-03 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,000 participants in total. It began in 2023-01-03 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Participant must be between 18 and 50 years of age at the time of signing the informed consent. 2. Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation 3. Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made 4. Participants carrying a fetus in vertex position 5. 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). Exclusion Criteria: 1. Multiple gestation 2. Elective cesarean section 3. Spontaneous start of labor 4. Known maternal intestinal stenosis, ileus or megacolon 5. Persisting maternal tachycardia (heart rate \> 130 beats per minute) \>30 minutes continuously. 6. Known maternal myasthenia gravis 7. Persisting fetal tachycardia (fetal heart rate baseline \> 170 beats per minute) \>30 minutes continuously. 8. Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride) 9. Women with heart disease who are under surveillance with heart rate monitoring during labor 10. Known fetal heart disease or known fetal malformations in the gastrointestinal system 11. Untreated maternal glaucoma 12. Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia 13. Maternal moderate/severe kidney failure (stage III-V: glomerulus filtration rate \<59 ml/minute/1.73m2 ) 14. Maternal elevated serum creatinine (\>90umol/L) 15. 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.
Contact & Investigator
Trond M Michelsen, MD PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05719467 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Labor Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05719467 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,000 participants.
Is NCT05719467 currently recruiting?
Yes, NCT05719467 is actively recruiting participants. Contact the research team at trmi1@ous-hf.no for enrollment information.
Where is the NCT05719467 trial being conducted?
This trial is being conducted at Lørenskog, Norway, Oslo, Norway, Oslo, Norway, Stavanger, Norway and 1 additional location.
Who is sponsoring the NCT05719467 clinical trial?
NCT05719467 is sponsored by Oslo University Hospital. The principal investigator is Trond M Michelsen, MD PhD at Oslo University Hospital. The trial plans to enroll 3,000 participants.