Prolonged Second Stage of Labor
Conditions
Keywords
angle of progression, cesarean delivery, transperineal ultrasound
Brief summary
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).
Interventions
DIAGNOSTIC_TESTTransperineal 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
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nulliparous or multiparous women with no history of vaginal delivery, * \> or = 37 weeks amenorrhoea * Cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound * uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours),
Exclusion criteria
* Multiparous women who were previous vaginal deliveries, * Presentation other than cephalic, * Twin pregnancies, * Posterior or transverse position * Transperineal ultrasound for head-perineum distance measurement * Fetal heart rate abnormalities requiring rapid delivery, * Contraindication to vaginal delivery whether maternal or fetal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cesarean delivery rate | baseline | Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of complicated deliveries in each group | baseline | 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 |
| Severe maternal morbidity, in each group | 1 month | 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. |
| Severe neonatal morbidity, in each group | 1 month | 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. |
| Rate of admission to neonatal intensive care unit, in each group | 1 month | Number of newborns admitted to intensive care out of the total number of newborns |
| Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading | 1 month | Centralized blind AOP measurement reading |
Countries
France
Contacts
Primary ContactRahamia Ahamada
Outcome results
None listed