Clinical trial NCT06449430: Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Official title: Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: compare the success rate of external cephalic version
timeFrame: Up to 24 months.
Secondary outcomes:
measure: ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.
timeFrame: Up to 24 months.
measure: 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.
timeFrame: Up to 24 months
measure: postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV
timeFrame: Up to 24 months
measure: 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
timeFrame: Up to 24 months
measure: rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.
timeFrame: Up to 24 months
measure: angle of progression of fetal presentation as a predictor of ECV success.
timeFrame: Up to 24 months
measure: angle of progression of fetal presentation as a predictor of complications of ECV.
timeFrame: Up to 24 months
measure: degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
References: