Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version (PropoSpinECV)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications
• Intervention / Treatment: Drug: Sedation with propofol; Drug: Spinal analgesia with bupivacaine

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Sanchez Romero, MD; Phone Number: 968 36 95 00; Email: javier.sanchez14@um.es
• Study Contact Backup: Name: Catalina De Paco Matallana, MD; Phone Number: 968 36 95 00; Email: katy.depaco@gmail.com

Study Locations

• Spain
  • Murcia
    • Murcia, Murcia, Spain, 30120
      • Recruiting
      • Hospital Clínico Universitario Virgen de la Arrixaca
      • Contact: Javier Sanchez Romero, MD; Phone Number: 968369500; Email: javier.sanchez14@um.es
      • Contact: Catalina De Paco Matalllana, MD; Phone Number: 968369500; Email: katy.depaco@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sedation with propofol; 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.	Drug: Sedation with propofol; Sedation with propofol
Active Comparator: bupivacaine; 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.	Drug: Spinal analgesia with bupivacaine; Spinal analgesia with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the success rate of external cephalic version	Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.	Up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.	Number of complications	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	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	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	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	Up to 24 months
angle of progression of fetal presentation as a predictor of ECV success.	angle of progression of fetal presentation	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.	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	Up to 24 months

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Anilides; Amides; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Bupivacaine; Propofol
• Other Study ID Numbers: IMIB-ECV-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No