SAINT: Safe Induction of Labor Trial (SAINT)
Labor Complication, Induced; Birth, Pregnancy Related
About this trial
This is an interventional treatment trial for Labor Complication
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Sites / Locations
- Akershus University HospitalRecruiting
- Oslo University Hospital RikshospitaletRecruiting
- Oslo University Hospital UllevålRecruiting
- Stavanger University HospitalRecruiting
- The University Hospital of North NorwayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Buscopan and bicarbonate
Buscopan and placebo
Placebo and bicarbonate
Placebo and placebo