Prolonged Second Stage of LaborDELIVERYNCT05779735
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate
A study testing Transperineal ultrasound measurements of AOP in people with Prolonged Second Stage of Labor, run by Hospital St. Joseph, Marseille, France at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolonged Second Stage of Labor
- What is being tested?
- Transperineal ultrasound measurements of AOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 7 sitesFrance
- Study dates
- 13 Sep 2023to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU de Lille - Hôpital Jeanne de Flandre
Lille, 59000
Charles GARABEDIAN
- Recruiting
APHM Hôpital Conception
Marseille, 13005
Florence Bretelle
- Recruiting
Hopital Saint Joseph
Marseille, 13008
Rahamia AHAMADA
Jean-Baptiste Haumonte
- Recruiting
APHM Hôpital Nord
Marseille, 13015
Pierre Castel
- Recruiting
Hôpital Armand Trousseau AP-HP
Paris, 75012
Anne PINTON
- Recruiting
CHIC Poissy
Poissy, 78300
Thibaud QUIBEL
- Recruiting
CHITS Hôpital Sainte Musse
Toulon, 83000
Franck MAUVIEL
About this study
Official title: Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
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).
- Conditions
- Prolonged Second Stage of Labor
- Being tested
- Transperineal ultrasound measurements of AOP
- Keywords
- angle of progression, cesarean delivery, transperineal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal ultrasound measurements of AOPDiagnostic test
The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head
| Study group | Role | What they receive |
|---|---|---|
| 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 :
* vaginal delivery is encouraged if AOP measurement is >120°
* cesarean delivery is encouraged if AOP measurement is <= 120° Receives: Diagnostic Test: Transperineal ultrasound measurements of AOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 month
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
Centralized blind AOP measurement reading
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start13 Sep 2023
- Primary completion13 Sep 2025 (estimated)
- Study completion13 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Second Stage of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Haumonte, Principal investigator, Hopital Saint Joseph Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779735
- Sponsor's protocol ID
- 2022-A01978-35 DELIVERY
- Acronym
- DELIVERY
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
- ClinicalTrials.gov ID
- NCT05779735
- Acronym / sponsor ID
- DELIVERY / 2022-A01978-35 DELIVERY
- Conditions
- Prolonged Second Stage of Labor
- Keywords
- angle of progression, cesarean delivery, transperineal ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 13 Sep 2025 (estimated)
- Study completion
- 13 Oct 2025 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Transperineal ultrasound measurements of AOPThe 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° |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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),
Key exclusion criteria (7 listed)
- Multiparous women who were previous vaginal deliveries,
- Presentation other than cephalic,
- Twin pregnancies,
- Posterior or transverse position
- Transperineal ultrasound for head-perineum distance measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal ultrasound measurements of AOPThe angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head | Diagnostic test | Group 2 : Transperineal ultrasound measurements of AOP |
Primary outcome
cesarean delivery rate
Time frame: baseline
Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours).
5 secondary outcomes
Number of complicated deliveries in each group
Time frame: baseline
Severe maternal morbidity, in each group
Time frame: 1 month
Severe neonatal morbidity, in each group
Time frame: 1 month
Rate of admission to neonatal intensive care unit, in each group
Time frame: 1 month
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
Related trials for Prolonged Second Stage of Labor
Recruiting
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
Prolonged Second Stage of Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Haumonte principal investigator
Hopital Saint Joseph Marseille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal ultrasound measurements of AOP in people with Prolonged Second Stage of Labor, run by Hospital St. Joseph, Marseille, France at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahamia Ahamada (0033488731071, rahamada@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cesarean delivery rate (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.