SAINT: Safe Induction of Labor Trial

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719467

Collaborator

(none)

3,000

Enrollment

Locations

Arms

58.9

Anticipated Duration (Months)

600

Patients Per Site

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.

Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.

Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.

The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

Condition or Disease	Intervention/Treatment	Phase
Labor Complication Induced; Birth Pregnancy Related	Drug: Buscopan 20 MG/ML Injectable Solution Drug: Sodium bicarbonate Drug: Placebo Drug: Nacl 0.9%	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Buscopan and bicarbonate	Drug: Buscopan 20 MG/ML Injectable Solution 1 mL intravenously Drug: Sodium bicarbonate 4 g orally
Active Comparator: Buscopan and placebo	Drug: Buscopan 20 MG/ML Injectable Solution 1 mL intravenously Drug: Placebo 4g orally Other Names: Oral Tab
Active Comparator: Placebo and bicarbonate	Drug: Sodium bicarbonate 4 g orally Drug: Nacl 0.9% 1 mL intravenously Other Names: Intravenous placebo
Placebo Comparator: Placebo and placebo	Drug: Placebo 4g orally Other Names: Oral Tab Drug: Nacl 0.9% 1 mL intravenously Other Names: Intravenous placebo

Outcome Measures

Primary Outcome Measures

Spontaneous vs operative birth [Through study completion, an average of one week]
Operative birth consists of cesarean section, forceps or vacuum delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Akershus University Hospital	Lørenskog	Norway
2	Oslo University Hospital Rikshospitalet	Oslo	Norway	0424
3	Oslo University Hospital Ullevål	Oslo	Norway
4	Stavanger University Hospital	Stavanger	Norway
5	The University Hospital of North Norway	Tromsø	Norway

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Trond M Michelsen, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trond Melbye Michelsen, Professor, Senior Consultant, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT05719467

Other Study ID Numbers:

235247

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obstetric Labor Complications

Butylscopolammonium Bromide

Study Results

No Results Posted as of Feb 9, 2023