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New treatment option for Labor Complication
Official title SAINT: Safe Induction of Labor Trial
ClinicalTrials.gov ID: NCT05719467
What this study is testing
What is Buscopan 20 MG/ML Injectable Solution?
Buscopan 20 MG/ML Injectable Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for labor complication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lørenskog, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lørenskog, Norway; Oslo, Norway; Stavanger, Norway; Tromsø, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.