ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06449430 (Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Who cites it
3 citing papers in PubMed.
- Development and Internal Validation of a Multivariable Prediction Model for Complications After External Cephalic Version in Singleton Term Pregnancies.Journal of clinical medicine · 2026Article
- External cephalic version outcomes with tocolysis and sedation: A 10-year retrospective cohort study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Ultrasound Assessment of Breech Engagement: Breech Progression Angle and Prediction of External Cephalic Version Success.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundExternal Cephalic Version (ECV) is an effective procedure for modifying fetal position to achieve a cephalic presentation. ECV is usually performed with tocolysis and spinal anesthesia. Recently, propofol has been proposed as a sedative agent for ECV, showing promising results in observational studies. This clinical trial aims to compare the outcomes of ECV performed under tocolysis with either propofol or spinal anesthesia.
methodsThe PropoSpinECV randomized clinical trial is designed as a single-center, randomized, open-label trial. Participation will be offered to every pregnant woman with a non-cephalic presentation undergoing external cephalic version. Sedation with propofol and spinal analgesia with bupivacaine and fentanyl will be compared for ECV with a 1:1 allocation ratio. All procedures will be performed under tocolysis with ritodrine. The breech progression angle before ECV will be measured for all participants. The main outcome will be the ECV success rate. ECV complication rates and post-procedure pain will also be evaluated. DISCUSSION: The PropoSpinECV trial will thoroughly evaluate the efficacy of propofol in ECV. Additionally, this trial will investigate the role of the breech progression angle prior to ECV as a predictive variable for the success of the procedure.
trial registrationThe PropoSpinECV clinical trial is registered in the European Union Clinical Trial Database (EU CT number: 2024-510701-29-00) and in the ClinicalTrials.gov Database (NCT06449430) with the Clinical Trial Registry (2024-06-03).
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