Safe Induction of Labor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.