SAINT: Safe Induction of Labor Trial

Launched by OSLO UNIVERSITY HOSPITAL · Feb 7, 2023

Keywords

ClinConnect Summary

The SAINT trial, or Safe Induction of Labor Trial, is studying how two medications—oral bicarbonate and intravenous butylscopolamine bromide—can help women have a safer and easier delivery when their labor is induced. Inducing labor is becoming more common, but it can lead to complications like needing a cesarean section or other interventions. The goal of this trial is to see if these medications can help more women deliver naturally without surgery.

To participate, women need to be between 18 and 50 years old, pregnant for at least 37 weeks, and have a single baby positioned head-down. They should also meet hospital criteria for needing labor induction. If you join the study, you can expect to receive one of the medications while your labor is being induced, and the researchers will monitor your progress. This trial is important because it aims to find safer options for women who need their labor induced, ultimately leading to better outcomes for both mothers and babies.

Gender

FEMALE

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.