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.

Start 3 Jan 2023 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 10 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 3,000

Countries 1

Sites 10

childbirth

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.

Key facts

Sponsor: Oslo University Hospital HF
Participant type: Patients
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 3 Jan 2023 → ongoing
Decision date (initial): 2024-10-09
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-511848-55-00
EudraCT number: 2021-000392-37
ClinicalTrials.gov: NCT05719467

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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.

Conditions and MedDRA coding

childbirth

Version	Level	Code	Term	System organ class
20.0	LLT	10055563	Labor induction	10042613

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Nulliparous women with induction of labor. Singleton fetus in cephalic presentation at term

Exclusion criteria 1

Spontaneous start of labor. Multifetal pregnancy. Known intolerance to study medications. Preterm birth.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Spontaneous vs operative delivery. Operative delivery defined as cesarean delivery, vacuum or forceps

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sodium Bicarbonate 500 mg Capsules

PRD10707305 · Product

Active substance: Sodium Hydrogen Carbonate
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 12 g gram(s)
Max total dose: 12 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A02AH — ANTACIDS WITH SODIUM BICARBONATE
Marketing authorisation: PL 51463/0137
MA holder: KENT PHARMA UK LIMITED
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Buscopan Ampoules 20mg/ml solution for injection.

PRD5277390 · Product

Active substance: Hyoscine Butylbromide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS INJECTION
Max daily dose: 60 mg milligram(s)
Max total dose: 60 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: A03BB01 — BUTYLSCOPOLAMINE
Marketing authorisation: PL 53886/0009
MA holder: OPELLA HEALTHCARE UK LIMITED, TRADING AS SANOFI
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 2

Sodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion

PRD10411934 · Product

Active substance: Sodium Chloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 3 ml millilitre(s)
Max total dose: 3 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: B05BB01 — ELECTROLYTES
Marketing authorisation: MA1123/00504
MA holder: FRESENIUS KABI ITALIA S.R.L.
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo tablets with same size and appearance as the bicarbonate tablets. Contents of placebo tablets are described in the SmPC.

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation: Oslo University Hospital HF
Address: Taarnbygget, Kirkeveien 166 Kirkeveien 166
City: Oslo
Postcode: 0450
Country: Norway

Scientific contact point

Organisation: Oslo University Hospital HF
Contact name: Trond

Public contact point

Organisation: Oslo University Hospital HF
Contact name: Trond

Locations

1 EU/EEA country · 10 investigational sites

By country

Country	MS status	Planned subjects	Sites
Norway	Ongoing, recruitment ended	3,000	10
Rest of world	—	0	—

Investigational sites

Norway

10 sites · Ongoing, recruitment ended

Oslo University Hospital HF

Department of Obstetrics and Gynecology, Taarnbygget, Kirkeveien 166, Oslo

Helse Stavanger HF

Department of Obstetrics and Gynecology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger

Helse Bergen HF

Department of Obstetrics and Gynecology, Haukelandsveien 22, 5021, Bergen

Sykehuset Oestfold HF Kalnes

Department of Obstetrics and Gynecology, Kalnesveien 300, 1714, Graalum

Sorlandet Sykehus HF

Department of Obstetrics and Gynecology, Egsveien 100, 4615, Kristiansand S

Baerum Sykehus

Department of Obstetrics and Gynecology, Sogneprest Munthe-Kaas Vei 100, 1346, Gjettum

St. Olavs Hospital HF

Department of Obstetrics and Gynecology, Prinsesse Kristinas G. 3, 7030, Trondheim

Universitetssykehuset Nord-Norge HF

Department of Obstetrics and Gynecology, Hansine Hansens Veg 67, 9019, Tromsoe

Akershus University Hospital

Department of Obstetrics and Gynecology, Sykehusveien 27, 1478, Lorenskog

Vestre Viken HF

Department of Obstetrics and Gynecology, Valbrottveien 17, 3024, Drammen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Norway	2023-01-03		2023-01-03	2025-01-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-511848-55-00	1
Protocol (for publication)	D1_Protocol 2024-511848-55-00_redacted	9
Recruitment arrangements (for publication)	Placeholder	1
Subject information and informed consent form (for publication)	Samtykke BARN_03JAN2023	5
Subject information and informed consent form (for publication)	Samtykkeskriv BARN engelsk_03JAN2023	5
Subject information and informed consent form (for publication)	Samtykkeskriv engelsk_03JAN2023_CTIS	5
Subject information and informed consent form (for publication)	Samtykkeskriv norsk_03JAN2023_CTIS	5
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Hyoscine Butyl Bromide	1
Summary of Product Characteristics (SmPC) (for publication)	G1_IMPD_Q_buscopan	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-09-09	Norway	Acceptable 2024-10-09	2024-10-09