Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT05719467
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05719467
Study Brief:
Protocol Section:
NCT05719467