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NCT Number: NCT06449430

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

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.

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sedation with propofol

Drug

Sedation with propofol

Spinal analgesia with bupivacaine

Drug

Spinal analgesia with bupivacaine

Primary outcomes

  1. compare the success rate of external cephalic version

    Time frame: Up to 24 months.

    Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.

Secondary outcomes

  1. ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.

    Time frame: Up to 24 months.

    Number of complications

  2. 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.

    Time frame: Up to 24 months

    Number of emergency cesarean

  3. postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV

    Time frame: Up to 24 months

    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

  4. 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

    Time frame: Up to 24 months

    number of episodes of hypotension hypotension

  5. rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.

    Time frame: Up to 24 months

    Level of nausea or vomiting in clinical history

  6. angle of progression of fetal presentation as a predictor of ECV success.

    Time frame: Up to 24 months

    angle of progression of fetal presentation

  7. angle of progression of fetal presentation as a predictor of complications of ECV.

    Time frame: Up to 24 months

    angle of progression of fetal presentation as a predictor of complications of ECV.

  8. degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)

    Time frame: Up to 24 months

    degree of tissue oxygenation

Study contacts

Contact information is provided by the study sponsor or research team.

Catalina De Paco Matallana, MD

CONTACT

[email protected]

968 36 95 00

Javier Sanchez Romero, MD

CONTACT

[email protected]

968 36 95 00

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PropoSpinECV

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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