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

Pregnancy Complications Clinical Trial

— PropoSpinECV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449430
• Other study ID #: IMIB-ECV-2024-01
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Javier Sanchez Romero, MD
• Phone: 968 36 95 00
• Email: javier.sanchez14[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Drug:
• Sedation with propofol
Sedation with propofol
• Spinal analgesia with bupivacaine
Spinal analgesia with bupivacaine

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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