Clinical trial • Phase III • Other

SODIUM HYDROGEN CARBONATE for Labor induction | Childbirth

Phase III trial of SODIUM HYDROGEN CARBONATE for Labor induction | Childbirth.

Overview

Trial Therapeutic Area
Other
Trial Disease
Labor induction | Childbirth
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-09-2024
First CTIS Authorization Date
09-10-2024

Trial design

Randomised, placebo comparator arms: oral placebo tablets matching the bicarbonate capsules ('placebo tablets with same size and appearance as the bicarbonate tablets. contents of placebo tablets are described in the smpc.') and 0.9% sodium chloride solution for infusion (placebo for iv administration). doses/schedules: placebo tablet content per smpc (not otherwise specified); placebo infusion is sodium chloride fresenius kabi italia 0.9% (route iv infusion).-controlled Phase III trial across 10 sites in Norway.

Randomised
Yes
Comparator
Placebo comparator arms: oral placebo tablets matching the bicarbonate capsules ('Placebo tablets with same size and appearance as the bicarbonate tablets. Contents of placebo tablets are described in the SmPC.') and 0.9% Sodium Chloride solution for infusion (placebo for IV administration). Doses/schedules: placebo tablet content per SmPC (not otherwise specified); placebo infusion is Sodium Chloride Fresenius Kabi Italia 0.9% (route IV infusion).
Target Sample Size
3000

Eligibility

Recruits 3000 Pregnant female participants are included and flagged as a vulnerable population. Consent is obtained from the pregnant participant; subject information and informed consent forms are provided in Norwegian and English. Child-specific information/consent documents are present (documents titled 'Samtykkeskriv BARN' and 'Samtykke BARN'), indicating procedures for child assent/consent where applicable. The application also states participants are asked to consent to sharing samples and non-identifiable data with other institutions including outside the EU/EEA..

Vulnerable Population
Pregnant female participants are included and flagged as a vulnerable population. Consent is obtained from the pregnant participant; subject information and informed consent forms are provided in Norwegian and English. Child-specific information/consent documents are present (documents titled 'Samtykkeskriv BARN' and 'Samtykke BARN'), indicating procedures for child assent/consent where applicable. The application also states participants are asked to consent to sharing samples and non-identifiable data with other institutions including outside the EU/EEA.

Inclusion criteria

  • {"criterion_text":"- Nulliparous women with induction of labor. Singleton fetus in cephalic presentation at term"}

Exclusion criteria

  • {"criterion_text":"- Spontaneous start of labor."}
  • {"criterion_text":"- Multifetal pregnancy."}
  • {"criterion_text":"- Known intolerance to study medications."}
  • {"criterion_text":"- Preterm birth."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Spontaneous vs operative delivery. Operative delivery defined as cesarean delivery, vacuum or forceps","definition_or_measurement_approach":"Operative delivery is defined as cesarean delivery, vacuum or forceps; the primary endpoint is a comparison of spontaneous versus operative delivery (binary outcome as defined)."}

Recruitment

Planned Sample Size
3000
Recruitment Window Months
25
Consent Approach
Informed consent obtained from the pregnant participant. Subject information and informed consent forms are provided in Norwegian and English ('Samtykkeskriv norsk_03JAN2023_CTIS' and 'Samtykkeskriv engelsk_03JAN2023_CTIS'). Child-specific information/consent documents are provided ('Samtykkeskriv BARN engelsk_03JAN2023' and 'Samtykke BARN_03JAN2023'), indicating procedures for assent/consent for minors where applicable. The application states participants are asked to consent to sharing samples and non-identifiable data with other Norwegian and international institutions.

Geography

Total Number Of Sites
10
Total Number Of Participants
3000

Norway

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
13
Number Of Sites
10
Number Of Participants
3000

Sites

Site Name
Helse Stavanger HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Ragnar Kvie
Contact Person Email
Ragnar.kvie.sande@sus.no
Site Name
Helse Bergen HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Jørg Kessler
Contact Person Email
jorg.kessler@kk.uib.no
Site Name
Vestre Viken HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Anne Molne Kjøllesdal
Site Name
Sykehuset Oestfold HF Kalnes
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Katrine D. Sjøborg
Site Name
Oslo University Hospital HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Trond Michelsen
Contact Person Email
trmi1@ous-hf.no
Site Name
Akershus University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Marit Camilla Haavaldsen
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Åse Torunn Revholt Pettersen
Site Name
Baerum Sykehus
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Tonje Anette Lippert
Contact Person Email
Tonje.Lippert@vestreviken.no
Site Name
Sorlandet Sykehus HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Marte Ween-Velken
Site Name
St. Olavs Hospital HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Elisabeth Balstad Magnussen

Sponsor

Primary sponsor

Full Name
Oslo University Hospital HF
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
Sodium Bicarbonate 500 mg Capsules
Active Substance
SODIUM HYDROGEN CARBONATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation PL 51463/0137)
Starting Dose
500 mg (capsule strength as stated)
Maximum Dose
12 g per day
Investigational Product Name
Buscopan Ampoules 20mg/ml solution for injection.
Active Substance
HYOSCINE BUTYLBROMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Authorisation Status
Authorised (marketing authorisation PL 53886/0009)
Maximum Dose
60 mg
Investigational Product Name
Placebo tablets with same size and appearance as the bicarbonate tablets. Contents of placebo tablets are described in the SmPC.
Modality
Other
Investigational Product Name
Sodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Authorised (MA1123/00504)
Maximum Dose
3 ml
Combination Treatment
Yes

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