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Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate (DELIVERY)

Primary Purpose

Prolonged Second Stage of Labor

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transperineal ultrasound measurements of AOP
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prolonged Second Stage of Labor focused on measuring angle of progression, cesarean delivery, transperineal ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Lille - Hôpital Jeanne de Flandre
  • APHM Hôpital Conception
  • Hopital Saint Joseph
  • APHM Hôpital Nord
  • Hôpital Armand Trousseau AP-HP
  • CHIC Poissy
  • CHITS Hôpital Sainte Musse

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1 : control

Group 2 : Transperineal ultrasound measurements of AOP

Arm Description

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°

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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.
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.
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
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
Centralized blind AOP measurement reading

Full Information

First Posted
March 9, 2023
Last Updated
March 29, 2023
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT05779735
Brief Title
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate
Acronym
DELIVERY
Official Title
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 3, 2023 (Anticipated)
Primary Completion Date
April 3, 2025 (Anticipated)
Study Completion Date
May 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Second Stage of Labor
Keywords
angle of progression, cesarean delivery, transperineal ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : control
Arm Type
No Intervention
Arm Description
The mode of delivery will be determined by clinical examens (digital examination)
Arm Title
Group 2 : Transperineal ultrasound measurements of AOP
Arm Type
Experimental
Arm Description
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°
Intervention Type
Diagnostic Test
Intervention Name(s)
Transperineal ultrasound measurements of AOP
Intervention Description
The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head
Primary Outcome Measure Information:
Title
cesarean delivery rate
Description
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
Secondary Outcome Measure Information:
Title
Number of complicated deliveries in each group
Description
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
Title
Severe maternal morbidity, in each group
Description
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
Title
Severe neonatal morbidity, in each group
Description
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
Title
Rate of admission to neonatal intensive care unit, in each group
Description
Number of newborns admitted to intensive care out of the total number of newborns
Time Frame
1 month
Title
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
Description
Centralized blind AOP measurement reading
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rahamia Ahamada
Phone
0033488731071
Email
rahamada@hopital-saint-joseph.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Haumonte
Organizational Affiliation
Hopital Saint Joseph Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Lille - Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles GARABEDIAN
Facility Name
APHM Hôpital Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Bretelle
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahamia AHAMADA
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Haumonte
Facility Name
APHM Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Castel
Facility Name
Hôpital Armand Trousseau AP-HP
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne PINTON
Facility Name
CHIC Poissy
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud QUIBEL
Facility Name
CHITS Hôpital Sainte Musse
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck MAUVIEL

12. IPD Sharing Statement

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Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate

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