Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : control | No Intervention | The mode of delivery will be determined by clinical examens (digital examination) | |
| Group 2 : Transperineal ultrasound measurements of AOP | Experimental | The mode of delivery will be determined by clinical examens (digital examination) and ultrasound measurement of the AOP :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transperineal ultrasound measurements of AOP | Diagnostic Test | The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complicated deliveries in each group | A complicated deliveries is defined by the occurrence of at least one of the following events :
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahamia Ahamada | Contact | 0033488731071 | rahamada@hopital-saint-joseph.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Haumonte | Hopital Saint Joseph Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille - Hôpital Jeanne de Flandre | Recruiting | Lille | 59000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline |
| Severe maternal morbidity, in each group | Severe maternal morbidity is defined by the occurrence of at least one of the following events:
| 1 month |
| Severe neonatal morbidity, in each group | Severe neonatal morbidity, in each group, defined by the occurrence of at least one event below:
| 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 | 1 month |
| Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading | Centralized blind AOP measurement reading | 1 month |
| APHM Hôpital Conception | Recruiting | Marseille | 13005 | France |
|
| Hopital Saint Joseph | Recruiting | Marseille | 13008 | France |
|
| APHM Hôpital Nord | Recruiting | Marseille | 13015 | France |
|
| Hôpital Armand Trousseau AP-HP | Recruiting | Paris | 75012 | France |
|
| CHIC Poissy | Recruiting | Poissy | 78300 | France |
|
| CHITS Hôpital Sainte Musse | Recruiting | Toulon | 83000 | France |
|