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

NCT ID: NCT06449430

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-06
• Study Completion Date: 2027-11-30

Brief 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. 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.

Conditions

Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sedation with propofol

Intervention Type: DRUG

Sedation with propofol

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.

Group Type: ACTIVE_COMPARATOR

Spinal analgesia with bupivacaine

Intervention Type: DRUG

Spinal analgesia with bupivacaine

Interventions

Sedation with propofol

Sedation with propofol

Intervention Type: DRUG

Spinal analgesia with bupivacaine

Spinal analgesia with bupivacaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Javier Sanchez Romero, MD

Role: CONTACT

javier.sanchez14@um.es

968 36 95 00

Catalina De Paco Matallana, MD

Role: CONTACT

katy.depaco@gmail.com

968 36 95 00

Facility Contacts

Javier Sanchez Romero, MD

Role: primary

javier.sanchez14@um.es

968369500

Catalina De Paco Matalllana, MD

Role: backup

katy.depaco@gmail.com

968369500

References

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.

Reference Type: DERIVED

PMID: 41068932 (View on PubMed)

Other Identifiers

IMIB-ECV-2024-01

Identifier Type: -

Identifier Source: org_study_id