Pregnancy ComplicationsPropoSpinECVNCT06449430
Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
A study testing Sedation with propofol and Spinal analgesia with bupivacaine in people with Pregnancy Complications, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Sedation with propofol and Spinal analgesia with bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jul 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation.
- Older than 18 years.
- Non-cephalic presentation.
- Desire to attempt a vaginal birth.
- Normal blood count and coagulation prior to the intervention
Who cannot join
- Age under 18 years old.
- Multiple gestation.
- Cephalic presentation.
- Risk of fetal compromise.
- Unexplained active bleeding.
- Absolute contraindication for vaginal delivery (Placenta Previa)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Javier Sanchez Romero, MD, 968369500, javier.sanchez14@um.es
Catalina De Paco Matalllana, MD, 968369500, katy.depaco@gmail.com
About this study
Official title: Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections.
Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.
Read the detailed description
This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are:
- To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia.
Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.
- Conditions
- Pregnancy Complications
- Being tested
- Sedation with propofol, Spinal analgesia with bupivacaine
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with propofolDrug
Sedation with propofol
Spinal analgesia with bupivacaineDrug
Spinal analgesia with bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Sedation with propofol | Experimental | Atropine 0.4 mg intravenous bolus and intravenous propofol will be administered through a continuous infusion with a target plasma concentration between 4-6 micrograms/mL maintaining a BIS between 65-75, following the protocol used by Sánchez-Romero J et al. (doi:10.3390/jcm11030489). For this, an intravenous infusion pump (Agilia SP TIVA ES, Fresenius Kabi AG, Bad Homburg, Germany) will be used. After the administration of propofol, a period of 3 minutes will be waited before starting the procedure to ensure the target plasma concentration. Receives: Drug: Sedation with propofol |
| bupivacaine | Active comparator | A combined spinal-epidural anesthesia technique will be performed with a spinal dose of 5-7.5 mg of hyperbaric bupivacaine and 20 μg of intrathecal fentanyl, along with the placement of an epidural catheter, following the protocol used by Brogly N et al. in "Protocols of the Obstetric Anesthesia Section of SEDAR, 2021". After the administration of epidural anesthesia, a period of 3 minutes will be waited before starting the procedure to ensure effective anesthesia. Receives: Drug: Spinal analgesia with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the success rate of external cephalic version
Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.
Measured: Up to 24 months.
Secondary outcomes (8)
ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.
Number of complications
Measured: Up to 24 months.
rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV.
Number of emergency cesarean
Measured: Up to 24 months
postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV
Visual Analogue Scale (VAS) pain consists of 9 items on which participants rate their perceived dizziness on a scale between 1 (no dizziness) and 10 (most dizziness) in different visual vertigo-inducing environments
Measured: Up to 24 months
rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV
number of episodes of hypotension hypotension
Measured: Up to 24 months
rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.
Level of nausea or vomiting in clinical history
Measured: Up to 24 months
angle of progression of fetal presentation as a predictor of ECV success.
angle of progression of fetal presentation
Measured: Up to 24 months
angle of progression of fetal presentation as a predictor of complications of ECV.
angle of progression of fetal presentation as a predictor of complications of ECV.
Measured: Up to 24 months
degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)
degree of tissue oxygenation
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start6 Jul 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449430
- Sponsor's protocol ID
- IMIB-ECV-2024-01
- Acronym
- PropoSpinECV
- Status last verified
- Nov 2025
- First submitted
- 28 May 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez-Romero J, Falcon-Arana L, Blanco-Carnero JE, Garcia-Ferreira J, Herrera-Gimenez J, Fuentes-Garcia D, Araico-Rodriguez F, Gallego-Pozuelo RM, Nieto-Diaz A, de Paco-Matallana C. Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial. Trials. 2025 Oct 9;26(1):398. doi: 10.1186/s13063-025-09105-0.
PubMed 41068932
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
- ClinicalTrials.gov ID
- NCT06449430
- Acronym / sponsor ID
- PropoSpinECV / IMIB-ECV-2024-01
- Conditions
- Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections.
Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.
Detailed description
This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are:
- To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia.
Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.
| Arm | Type | Receives |
|---|---|---|
| Sedation with propofol | Experimental | Drug: Sedation with propofolAtropine 0.4 mg intravenous bolus and intravenous propofol will be administered through a continuous infusion with a target plasma concentration between 4-6 micrograms/mL maintaining a BIS between 65-75, following the protocol used by Sánchez-Romero J et al. (doi:10.3390/jcm11030489). For this, an intravenous infusion pump (Agilia SP TIVA ES, Fresenius Kabi AG, Bad Homburg, Germany) will be used. After the administration of propofol, a period of 3 minutes will be waited before starting the procedure to ensure the target plasma concentration. |
| bupivacaine | Active comparator | Drug: Spinal analgesia with bupivacaineA combined spinal-epidural anesthesia technique will be performed with a spinal dose of 5-7.5 mg of hyperbaric bupivacaine and 20 μg of intrathecal fentanyl, along with the placement of an epidural catheter, following the protocol used by Brogly N et al. in "Protocols of the Obstetric Anesthesia Section of SEDAR, 2021". After the administration of epidural anesthesia, a period of 3 minutes will be waited before starting the procedure to ensure effective anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary participation.
- Older than 18 years.
- Non-cephalic presentation.
- Desire to attempt a vaginal birth.
- Normal blood count and coagulation prior to the intervention
Key exclusion criteria (14 listed)
- Age under 18 years old.
- Multiple gestation.
- Cephalic presentation.
- Risk of fetal compromise.
- Unexplained active bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation with propofolSedation with propofol | Drug | Sedation with propofol |
| Spinal analgesia with bupivacaineSpinal analgesia with bupivacaine | Drug | bupivacaine |
Primary outcome
compare the success rate of external cephalic version
Time frame: Up to 24 months.
Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.
8 secondary outcomes
ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.
Time frame: Up to 24 months.
rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV.
Time frame: Up to 24 months
postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV
Time frame: Up to 24 months
rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV
Time frame: Up to 24 months
rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.
Time frame: Up to 24 months
angle of progression of fetal presentation as a predictor of ECV success.
Time frame: Up to 24 months
angle of progression of fetal presentation as a predictor of complications of ECV.
Time frame: Up to 24 months
degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41068932Sanchez-Romero J, Falcon-Arana L, Blanco-Carnero JE, Garcia-Ferreira J, Herrera-Gimenez J, Fuentes-Garcia D, Araico-Rodriguez F, Gallego-Pozuelo RM, Nieto-Diaz A, de Paco-Matallana C. Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial. Trials. 2025 Oct 9;26(1):398. doi: 10.1186/s13063-025-09105-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation with propofol and Spinal analgesia with bupivacaine in people with Pregnancy Complications, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Sanchez Romero, MD (968 36 95 00, javier.sanchez14@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the success rate of external cephalic version (time frame: Up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.