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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation with propofol | Experimental | 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. |
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| bupivacaine | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation with propofol | Drug | Sedation with propofol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| compare the success rate of external cephalic version | Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia. | Up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia. | Number of complications | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Sanchez Romero, MD | Contact | 968 36 95 00 | javier.sanchez14@um.es | |
| Catalina De Paco Matallana, MD | Contact | 968 36 95 00 | katy.depaco@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario Virgen de la Arrixaca | Recruiting | Murcia | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41068932 | Derived | Sanchez-Romero J, Falcon-Arana L, Blanco-Carnero JE, Garcia-Ferreira J, Herrera-Gimenez J, Fuentes-Garcia D, Araico-Rodriguez F, Gallego-Pozuelo RM, Nieto-Diaz A, de Paco-Matallana C. Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial. Trials. 2025 Oct 9;26(1):398. doi: 10.1186/s13063-025-09105-0. |
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An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.
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| Spinal analgesia with bupivacaine |
| Drug |
Spinal analgesia with bupivacaine |
|
Number of emergency cesarean |
| 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 | 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 | 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 | Up to 24 months |
| angle of progression of fetal presentation as a predictor of ECV success. | angle of progression of fetal presentation | 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. | 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 | Up to 24 months |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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