An interventional study of Transperineal ultrasound measurements of AOP in Prolonged Second Stage of Labor, sponsored by Hospital St. Joseph, Marseille, France. Recruiting at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Other
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Ultrasound during labor and measurement of Angle of progression showed extensive prospective and retrospective publications since 2010. The investigators performed between 2013 and 2016 the only one multicenter, randomized controlled Trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. The investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position This randomised PILOT study showed that measurement of Angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018.
The objective of this new study is therefore to validate the results of this PILOT study in a more powerful multicenter randomized trial (DELIVERY).
Hospital St. Joseph, Marseille, France is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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Contraindication
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The mode of delivery will be determined by clinical examens (digital examination)
The mode of delivery will be determined by clinical examens (digital examination) and ultrasound measurement of the AOP : * vaginal delivery is encouraged if AOP measurement is \>120° * cesarean delivery is encouraged if AOP measurement is \<= 120°
Diagnostic Test: Transperineal ultrasound measurements of AOP
The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head
cesarean delivery rate
Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours).
Time frame: baseline
Number of complicated deliveries in each group
A complicated deliveries is defined by the occurrence of at least one of the following events : * Failed instrumental extraction * Sequential use of a second instrument, * Difficult instrumental extraction defined as : * vacuum detachment * requires the use of a second instrument, * extraction time \> 10 minutes, * operator's impression of the difficulty of extraction, * Shoulder dystocia by obstetric maneuver
Time frame: baseline
Severe maternal morbidity, in each group
Severe maternal morbidity is defined by the occurrence of at least one of the following events: * postpartum hemorrhage requiring hysterectomy, embolization, conservative surgical treatment or blood transfusion, * third or fourth degree perineal tears * vaginal thrombus, * cervical tear, * surgical wounds * sepsis, amniotic embolism, cardiac complication or renal failure.
Time frame: 1 month
Severe neonatal morbidity, in each group
Severe neonatal morbidity, in each group, defined by the occurrence of at least one event below: * severe biological signs * moderate or absent biological signs but associated with perinatal events * seizure * severe neonatal trauma * Fetal death or neonatal death.
Time frame: 1 month
Rate of admission to neonatal intensive care unit, in each group
Number of newborns admitted to intensive care out of the total number of newborns
Time frame: 1 month
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
Centralized blind AOP measurement reading
Time frame: 1 month
Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.
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Hospital St. Joseph, Marseille, France