Midazolam for Breech (podalic) or transverse fetal presentation (dystocic fetal presentation)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Patient presenting with a dystocic (podalic or transverse) fetus at 36 weeks' gestation\n- Patient covered by a social insurance system\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Obstetrical contraindications : - Placenta previa ; - 3rd trimester metrorrhagia; - Suspicion of foetal anoxia; - Patient who has already had more than one caesarean section; - Twin pregnancies; - HIV+; - Anticoagulant treatment in progress\n- Anaesthetic contraindications : - Infection at the puncture site, generalised infection or severe septic state; - Intracranial hypertension; - Uncompensated heart failure; - Constitutive or acquired coagulation anomalies, including curative anticoagulant treatments; - Neuropathy with demyelination of nerve fibres in advanced stages or in the process of unstabilised recovery; - Syringomyelia\n- Patient deprived of liberty, under legal protection (guardianship or curatorship), unable to read or write."}

Primary endpoints

• {"endpoint_text":"- Successful EMV once the procedure has been completed, i.e. a foetus in cephalic presentation.","definition_or_measurement_approach":"Defined as obtaining a foetus in cephalic presentation once the external cephalic version procedure has been completed."}

Secondary endpoints

• {"endpoint_text":"- Events secondary to the procedure: caesarean section for permanent bradycardia, retroplacental haematoma, rupture of membranes","definition_or_measurement_approach":"Occurrence of procedure-related events including caesarean section for permanent fetal bradycardia, retroplacental haematoma, and rupture of membranes."}
• {"endpoint_text":"- Events secondary to the anaesthetic: hypotension, bradycardia, desaturation, nausea/vomiting, number of punctures greater than 11 (failure of the first spinal puncture and need for one or more others)","definition_or_measurement_approach":"Occurrence of anaesthesia-related adverse events (hypotension, bradycardia, desaturation, nausea/vomiting) and count of punctures; number of punctures > 11 considered as failure of first spinal puncture."}
• {"endpoint_text":"- The pain felt by the patient: assessed by VAS","definition_or_measurement_approach":"Patient-reported pain measured using the visual analogue scale (VAS/EVA)."}
• {"endpoint_text":"- Final route of delivery","definition_or_measurement_approach":"Recorded final mode of delivery (vaginal/natural route or caesarean section)."}
• {"endpoint_text":"- Presentation at delivery","definition_or_measurement_approach":"Recorded fetal presentation at delivery (cephalic or podalic)."}

France

Latest Decision Or Authorization Date

30-09-2024

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France