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SAINT: Safe Induction of Labor Trial (SAINT)

Primary Purpose

Labor Complication, Induced; Birth, Pregnancy Related

Status
Recruiting
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Buscopan 20 MG/ML Injectable Solution
Sodium bicarbonate
Placebo
Nacl 0.9%
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Complication

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Akershus University HospitalRecruiting
  • Oslo University Hospital RikshospitaletRecruiting
  • Oslo University Hospital UllevålRecruiting
  • Stavanger University HospitalRecruiting
  • The University Hospital of North NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Buscopan and bicarbonate

Buscopan and placebo

Placebo and bicarbonate

Placebo and placebo

Arm Description

Outcomes

Primary Outcome Measures

Spontaneous vs operative birth
Operative birth consists of cesarean section, forceps or vacuum delivery

Secondary Outcome Measures

Full Information

First Posted
December 18, 2022
Last Updated
February 7, 2023
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05719467
Brief Title
SAINT: Safe Induction of Labor Trial
Acronym
SAINT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication, Induced; Birth, Pregnancy Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Buscopan and bicarbonate
Arm Type
Active Comparator
Arm Title
Buscopan and placebo
Arm Type
Active Comparator
Arm Title
Placebo and bicarbonate
Arm Type
Active Comparator
Arm Title
Placebo and placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Buscopan 20 MG/ML Injectable Solution
Intervention Description
1 mL intravenously
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
4 g orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Oral Tab
Intervention Description
4g orally
Intervention Type
Drug
Intervention Name(s)
Nacl 0.9%
Other Intervention Name(s)
Intravenous placebo
Intervention Description
1 mL intravenously
Primary Outcome Measure Information:
Title
Spontaneous vs operative birth
Description
Operative birth consists of cesarean section, forceps or vacuum delivery
Time Frame
Through study completion, an average of one week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trond M Michelsen, MD PhD
Phone
+4723070000
Email
trmi1@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trond M Michelsen, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Haavaldsen, MD, PhD
Facility Name
Oslo University Hospital Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trond M Michelsen, MD, PhD
Phone
+472307000
Email
trmi1@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Ingvil K Sorbye, MD, PhD
Phone
+4723072640
Email
isorbye@ous-hf.no
Facility Name
Oslo University Hospital Ullevål
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne F Jacobsen, MD, PhD
Email
uxafja@ous-hf.no
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragnar K Sande, MD, PhD
Facility Name
The University Hospital of North Norway
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åse T Pettersen, MD

12. IPD Sharing Statement

Learn more about this trial

SAINT: Safe Induction of Labor Trial

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