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

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

Status: Enrolling

Conditions: Pregnancy Complications

Treatments: Drug: Sedation with propofol; Drug: Spinal analgesia with bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06449430

IMIB-ECV-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Sedation with propofol

Experimental group

Description:

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.

Treatment:

Drug: Sedation with propofol

bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Spinal analgesia with bupivacaine