Clinical trial • Not applicable • Other
Propofol for External cephalic version
Not applicable trial of Propofol for External cephalic version.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- External cephalic version
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-03-2024
- First CTIS Authorization Date
- 20-05-2024
Trial design
Randomised, comparator arms: fentanest 0,05 mg/ml solution for injection (fentanyl citrate) and bupivacaína b. braun 5 mg/ml solución inyectable (bupivacaine hydrochloride). no dose schedule or administration schedule specified in the record.-controlled Not applicable trial in Spain.
- Randomised
- Yes
- Comparator
- Comparator arms: Fentanest 0,05 mg/ml solution for injection (fentanyl citrate) and Bupivacaína B. Braun 5 mg/ml solución inyectable (bupivacaine hydrochloride). No dose schedule or administration schedule specified in the record.
- Target Sample Size
- 270
Eligibility
Recruits 270 Vulnerable population selected: pregnant women (isVulnerablePopulationSelected = true). Consent statement provided: "Voluntary participation." No further details on assent/consent handling, age-specific consent documents or languages available are provided in the record..
- Vulnerable Population
- Vulnerable population selected: pregnant women (isVulnerablePopulationSelected = true). Consent statement provided: "Voluntary participation." No further details on assent/consent handling, age-specific consent documents or languages available are provided in the record.
Inclusion criteria
- {"criterion_text":"- Voluntary participation.\n- Older than 18 years\n- Non-cephalic presentation.\n- Desire to attempt a vaginal birth.\n- Normal blood count and coagulation prior to the intervention"}
Exclusion criteria
- {"criterion_text":"- Age under 18 years old.\n- Thrombocytopenia (<85,000 platelets).\n- Maternal spinal anomaly.\n- Intolerance or allergy to Propofol or any of its components.\n- Intolerance or allergy to bupivacaine or any of its components.\n- Contraindication for intrathecal sedation or analgesia\n- Multiple gestation.\n- Cephalic presentation.\n- Risk of fetal compromise.\n- Unexplained active bleeding.\n- Absolute contraindication for vaginal delivery (Placenta Previa)\n- 2 or more previous cesarean sections.\n- Previous myomectomy with entry into the uterine cavity.\n- Maternal fever."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary end point is the ECV outcome.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 270
- Recruitment Window Months
- 26
- Consent Approach
- Voluntary participation. No further details on the informed consent/assent process, who provides consent beyond the participant, age-specific consent forms, or languages available are provided in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 270
Spain
- Earliest CTIS Part Ii Submission Date
- 16-04-2024
- Latest Decision Or Authorization Date
- 20-05-2024
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 270
Sites
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Ginecología y Obtetricia
- Contact Person Name
- Javier Sánchez Romero
- Contact Person Email
- javier.sanchez14@um.es
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Third parties
- {"country":"","full_name":"Instituto de Salud Carlos III (ICI23/00011)","duties_or_roles":"Monetary support / funding","organisation_type":""}
Investigational products
- Investigational Product Name
- Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión
- Active Substance
- Propofol
- Modality
- Small molecule
- Routes Of Administration
- EPIDURAL USE
- Route
- EPIDURAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 6 µg
- Investigational Product Name
- Fentanest 0,05 mg/ml solución inyectable
- Active Substance
- Fentanyl citrate
- Modality
- Small molecule
- Routes Of Administration
- EPIDURAL USE
- Route
- EPIDURAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 20 µg
- Investigational Product Name
- Bupivacaína B. Braun 5 mg/ml solución inyectable
- Active Substance
- Bupivacaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- EPIDURAL USE
- Route
- EPIDURAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 7.5 mg
- Combination Treatment
- Yes
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