Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
270
Countries
1
Sites
1
External Cephalic Version
The main objective of the project is to compare the success rate of ECV when used Propofol as a sedative agent or spinal analgesia.
Key facts
- Sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 4 Jul 2024 → ongoing
- Decision date (initial)
- 2024-05-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III (ICI23/00011)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective of the project is to compare the success rate of ECV when used Propofol as a sedative agent or spinal analgesia.
Secondary objectives 8
- Compare the complication rate of ECV when using Propofol as an agent sedative or spinal analgesia.
- Compare the rate of emergency cesarean sections in the first 24 hours after procedure when Propofol is used as a sedative agent or spinal analgesia in the ECV.
- Compare post-procedure pain when using Propofol as a sedative agent or spinal analgesia in the ECV.
- Compare the rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as an agent sedative or spinal analgesia in the ECV.
- Compare the rate of nausea or vomiting when using Propofol as an agent sedative or spinal analgesia in the ECV.
- Analyze the angle of progression of fetal presentation as a predictor of success of the ECV
- Analyze the angle of progression of fetal presentation as a predictor of complications of ECV.
- Describe the degree of tissue oxygenation of the placenta during ECV using the analysis of a pilot sample with infrared spectroscopy (NIRS)
Conditions and MedDRA coding
External Cephalic Version
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10070636 | External cephalic version | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Voluntary participation.
- Older than 18 years
- Non-cephalic presentation.
- Desire to attempt a vaginal birth.
- Normal blood count and coagulation prior to the intervention
Exclusion criteria 14
- Age under 18 years old.
- Multiple gestation.
- Cephalic presentation.
- Risk of fetal compromise.
- Unexplained active bleeding.
- Absolute contraindication for vaginal delivery (Placenta Previa)
- 2 or more previous cesarean sections.
- Previous myomectomy with entry into the uterine cavity.
- Maternal fever.
- Thrombocytopenia (<85,000 platelets).
- Maternal spinal anomaly.
- Intolerance or allergy to Propofol or any of its components.
- Intolerance or allergy to bupivacaine or any of its components.
- Contraindication for intrathecal sedation or analgesia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary end point is the ECV outcome.
Secondary endpoints 1
- Secondary outcome variables are complications of ECV, urgent cesarean section during the first 24 hours after the procedure, VAS scale, postoperative pain survey, clinically relevant hypotension, nausea, vomiting.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión
PRD409198 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- EPIDURAL USE
- Max daily dose
- 6 µg microgram(s)
- Max total dose
- 6 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 62.134
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Fentanest 0,05 mg/ml solución inyectable
PRD406442 · Product
- Active substance
- Fentanyl Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- EPIDURAL USE
- Max daily dose
- 20 µg microgram(s)
- Max total dose
- 20 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- 41.764
- MA holder
- KERN PHARMA, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bupivacaína B. Braun 5 mg/ml solución inyectable
PRD568914 · Product
- Active substance
- Bupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- EPIDURAL USE
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 7.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 62411
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Sponsor organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Address
- Carretera De Cartagena S/n, El Palmar El Palmar
- City
- Murcia
- Postcode
- 30120
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- María Muñoz García
Public contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- María Muñoz García
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 270 | 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 |
|---|---|---|---|---|---|
| Spain | 2024-07-04 | 2024-07-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-01 | Spain | Acceptable 2024-05-14
|
2024-05-20 |