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Clinical Trials in Spain / NCT06449430
Recruiting Not applicable

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

NCT06449430 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-07-06
Last updated
2025-11-21

Condition(s) studied

Pregnancy Complications

Investigational drug(s) / intervention(s)

Sedation with propofolSpinal analgesia with bupivacaine

Sedation with propofol: Sedation with propofol

Spinal analgesia with bupivacaine: Spinal analgesia with bupivacaine

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Murcia Recruiting

More Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06449430 on ClinicalTrials.gov ↗ ← All trials in Spain