Safe Induction of Labor
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
This study tests whether using Buscopan, sodium bicarbonate, or a placebo can make labor induction safer and more effective for first-time pregnant women who are at least 37 weeks along.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 5 sites (Lørenskog and 4 other locations) |
| Trial ID | NCT05719467 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of different interventions for inducing labor in pregnant women who meet specific criteria. It focuses on women who are nulliparous, at or above 37 weeks of gestation, and have a decision made for labor induction. The study aims to evaluate the outcomes of using Buscopan, sodium bicarbonate, and placebo in comparison to standard care. By analyzing the rates of adverse obstetric outcomes, the trial seeks to improve the induction process and minimize risks associated with labor induction.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 50 who are nulliparous and at or above 37 weeks of gestation with a decision to induce labor.
Not a fit: Patients with multiple gestations, those opting for elective cesarean sections, or those experiencing spontaneous labor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective labor induction methods, reducing complications for both mothers and infants.
How similar studies have performed: Other studies have shown varying degrees of success with labor induction methods, but this specific approach is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lørenskog and 4 other locations
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Oslo University Hospital Rikshospitalet — Oslo, Norway (Recruiting)
- Oslo University Hospital Ullevål — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- The University Hospital of North Norway — Tromsø, Norway (Recruiting)
Study contacts
- Principal investigator: Trond M Michelsen, MD PhD — Oslo University Hospital
- Study coordinator: Trond M Michelsen, MD PhD
- Email: trmi1@ous-hf.no
- Phone: +4723070000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.