An interventional study of Sedation with propofol and Spinal analgesia with bupivacaine in Pregnancy Complications, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Not applicable, Interventional, and Treatment
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.
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:
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.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
This study's planned enrollment of 270 is above the median of 144 across 205 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sedation with propofol
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.
Drug: Spinal analgesia with bupivacaine
Drug page: Propofol
Sedation with propofol
Spinal analgesia with bupivacaine
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.
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.
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
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
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
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
Time frame: Up to 24 months
angle of progression of fetal presentation as a predictor of ECV success.
angle of progression of fetal presentation
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)
degree of tissue oxygenation
Time frame: Up to 24 months
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Oct 2027, 39 months after the start.
Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 39 months is above that.
Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Propofol
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia