Overview
Sponsor-declared trial summary
anaesthesia: comparison of spinal anaesthesia with sedation
is to show that spinal anaesthesia allows a higher success rate than simple sedation for programmed VME, i.e. to transform a podalic or transverse foetal presentation into a cephalic presentation, the presentation being defined by the foetal pole closest to the cervix.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 30 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517302-29-00
- EudraCT number
- 2016-000059-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
is to show that spinal anaesthesia allows a higher success rate than simple sedation for programmed VME, i.e. to transform a podalic or transverse foetal presentation into a cephalic presentation, the presentation being defined by the foetal pole closest to the cervix.
Secondary objectives 4
- The occurrence of events secondary to the procedure: caesarean section for permanent bradycardia (slowing of the foetal heart rate), retroplacental haematoma, rupture of the amniotic membranes
- The pain felt by the patient: subjectively assessed by the patient using the visual analogue scale, or VAS (internationally validated scale)
- The final route of delivery (natural route or caesarean section)
- Presentation at delivery (cephalic or podalic)
Conditions and MedDRA coding
anaesthesia: comparison of spinal anaesthesia with sedation
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Etude prospective, contrôlée, randomisée, en groupes parallèles, en intention de traiter, en ouvert groupe 1 : 0,10 mg/kg de midazolam en sublinguale
groupe 2 : rachianesthésie de 10 mg de bupivacaine avec une aiguille de 25 gauge en position assise en respectant les règles d’asepsie conventionnelle
|
Randomised Controlled | None | Groupe contrôle: 0,10 mg/kg de midazolam en sublinguale Groupe intervention: rachianesthésie de 10 mg de bupivacaine avec une aiguille de 25 gauge en position assise en respectant les règles d’asepsie conventionnelle |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years
- Patient presenting with a dystocic (podalic or transverse) fetus at 36 weeks' gestation
- Patient covered by a social insurance system
- Signed informed consent
Exclusion criteria 3
- Obstetrical contraindications : - Placenta previa ; - 3rd trimester metrorrhagia; - Suspicion of foetal anoxia; - Patient who has already had more than one caesarean section; - Twin pregnancies; - HIV+; - Anticoagulant treatment in progress
- Anaesthetic contraindications : - Infection at the puncture site, generalised infection or severe septic state; - Intracranial hypertension; - Uncompensated heart failure; - Constitutive or acquired coagulation anomalies, including curative anticoagulant treatments; - Neuropathy with demyelination of nerve fibres in advanced stages or in the process of unstabilised recovery; - Syringomyelia
- Patient deprived of liberty, under legal protection (guardianship or curatorship), unable to read or write.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Successful EMV once the procedure has been completed, i.e. a foetus in cephalic presentation.
Secondary endpoints 5
- Events secondary to the procedure: caesarean section for permanent bradycardia, retroplacental haematoma, rupture of membranes
- Events secondary to the anaesthetic: hypotension, bradycardia, desaturation, nausea/vomiting, number of punctures greater than 11 (failure of the first spinal puncture and need for one or more others)
- The pain felt by the patient: assessed by VAS
- Final route of delivery
- Presentation at delivery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Midazolam 1 mg/ml Solution for Injection or Infusion
PRD8603869 · Product
- Active substance
- Midazolam
- Substance synonyms
- USL-261
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.10 mg/kg milligram(s)/kilogram
- Max total dose
- 0.10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- PL 20075/0080
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
BUPIVACAINE VIATRIS 20 mg/4 ml, solution injectable pour voie intra rachidienne en ampoule
PRD11453526 · Product
- Active substance
- Bupivacaine Hydrochloride, Anhydrous
- Substance synonyms
- ANHYDROUS BUPIVACAINE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 3400956311651
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- FOULON Arthur
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- FOULON Arthur
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2024-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2016-000059-29_Tableau comparatif_V6_20231017_RaVeM | 6 |
| Protocol (for publication) | D1_Protocol 2024-517302-29-00 | 1.7 |
| Protocol (for publication) | D1_Protocol 2024-517302-29-00 | 1.7 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_PATIENT | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_PATIENT | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BUPIVACAINE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPCF_Midazolam | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-20 | France | Acceptable 2024-09-23
|
2024-09-30 |