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NCT02801201: RaVem
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation
Phase 3 trial testing Midazolam in Breech Presentation in 200 participants. Status unknown.
30 October 2019
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 31 May 2016 |
| Primary completion | 30 October 2019 |
| Estimated completion | 30 November 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Bupivacaine (BUPIVACAINE) — full drug profile →
Conditions studied
- Breech Presentation — all drugs for Breech Presentation →
Sponsor
Centre Hospitalier Universitaire, Amiens
Who can join
Adults 18 to 60, female only, with Breech Presentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02801201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting
Other recruiting trials for Breech Presentation
Currently open trials in the same condition.
- NCT06187948 — An Informative Video Before Planned External Cephalic Version · NA · recruiting
- NCT06816563 — Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle · recruiting
- NCT04579835 — Twin A Breech External Cephalic Version Intervention Trial (TWEXIT) · recruiting
Other Centre Hospitalier Universitaire, Amiens trials
Trials by the same sponsor.
- NCT07354568 — Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock · recruiting
- NCT07071662 — Induction of Labor in Breech Presentation · completed
- NCT06909487 — Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respec · completed
- NCT07037719 — Automatic Detection of Eligible Patients to RAUC Protocol (RAUCISABLE) · recruiting
- NCT06996145 — Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02801201 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens
- Last refreshed: 8 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02801201.
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