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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation.

Older than 18 years.

Non-cephalic presentation.

Desire to attempt a vaginal birth.

Disqualifiers

Age under 18 years old.

Multiple gestation.

Cephalic presentation.

Risk of fetal compromise.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sedation with propofol

    Drug

    Sedation with propofol

  • Spinal analgesia with bupivacaine

    Drug

    Spinal analgesia with bupivacaine

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Sedation with propofolExperimental treatment 1 intervention
Group B: bupivacaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

compare the success rate of external cephalic version

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

Time frame
Up to 24 months.

Secondary outcomes

1

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

Number of complications

Time frame
Up to 24 months.
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.

Number of emergency cesarean

Time frame
Up to 24 months
3

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

Time frame
Up to 24 months
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

number of episodes of hypotension hypotension

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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