AzTrials
AzTrials

Caesarean Rateeng - echoNCT02761304

Assessment of the Interests of Mesure of Ultrasound " Angle of Progression " on the Cesarean Rate :a Randomized Comparative Prospective Study Multicenter Center Open

A study testing Ultrasound in people with Caesarean Rate, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The reduction in the rate of caesarean section is a major public health issue, it has reached 21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth increase doubles the risk of fetal morbidity, néonatal and maternal history of when césareinne. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Caesarean Rate
What is being tested?
Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
Jun 2013to Oct 2021
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

  • Singleton pregnancy normal evolution> 37 weeks gestation
  • Patient in labor with ruptured membranes, cephalic presentation, full dilatation since 2H, with doubts on clinical examination on the level of engagement of the fetal head in the maternal pelvis (0, +1, +2)

Who cannot join

  • Abnormal fetal heart rate or suspected fetal acidosis on a scale pH
  • No maternal indication for vaginal delivery or instrumental delivery
  • History of perineal tearing the 4th degree
  • Crohn's disease with involvement of the anal sphincter
  • No fetal indication for instrumental delivery (suspected fetal thrombocytopenia)
  • Other than fetal cephalic presentations

Trial locations and contacts

1 site in 1 country.

France1 site
  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354

Other trials in France

About this study

Official title: Assessment of the Interests of Mesure of Ultrasound Engagement on the Cesarean Rate :Study Eng - Echo Randomized Comparative Prospective Study Multicenter Center Open

The reduction in the rate of caesarean section is a major public health issue, it has reached 21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth increase doubles the risk of fetal morbidity, néonatal and maternal history of when césareinne. recommendations for clinical practice (RPC) to "scarred uterus" are being drafted under the auspices of the National College of obstetrics and gynecology (CNGOF) well highlighting the health problem public this represents. During 2011, 15% of the 2,700 patients who have recently given birth to the north of Marseille Hospital were carriers of a scarred uterus (internal data).The objective of the obstetrician is to ensure the welfare mother and fetus at the end of pregnancy and childbirth. To do this, the realization of a work being cesarean allows in some cases to reduce neonatal morbidity related to workflow especially in case of abnormal fetal pericardial pace that suggest fetal hypoxia. However, a significant number of caesarean section is performed by the side of caution during the second part of the work to a suspicion of non-engagement of the fetal presentation. These caesareans are indicated, rightly, before a clinical doubt about the height of the engagement of the fetal presentation in order to avoid making a difficult instrumental delivery, potentially harmful to the mother (perineal tear 3rd and 4th degree) and fetus (head injury, intracranial hemorrhage, cephalohematoma). A prospective study published in the Lancet estimated 37% error percentage attributable to the clinical examination in case of doubt on the commitment of presenatation fœtale. The CNGOF held through PRC publication what to do in case of obstetric clinical doubt about the commitment of the fetal presentation and "not recommended" no show against an instrumental extraction in this situation (RPC 2008).

Ultrasound has revolutionized pregnancy monitoring. Its routine use has in other prenatal diagnosis of fetal pathologies, it is the other reference screening tool of the most common obstetric pathology, preterm labor. Its use became widespread in the delivery room, the presence of an ultrasound machine is recommended by the decrees of perinatal care in maternity hospitals performing more than 1,500 deliveries per year. It is natural for conducting ultrasound during labor has emerged, first to help identify the variety of the presentation of the fetal head and then more recently in aid to instrumental delivery. Several studies have shown that ultrasound had a sensitivity of commitment over 90% for predicting the success of instrumental extraction and a vaginal delivery.

To our knowledge, to date, there is no study that investigated the benefit of ultrasound commitment to reduce the rate of cesarean section during labor. To answer this question, we want to show that making a commitment in case of diagnostic ultrasound of doubt about the level of engagement of the fetal head (4% of births) reduces by 30% the rate of caesarean section fully dilated.

Conditions
Caesarean Rate
Being tested
Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundProcedure or surgery

Study groups in NCT02761304
Study groupRoleWhat they receive
ultrasound results given to obstetrical practionnairExperimentalNot described
Receives: Procedure: Ultrasound
ultrasound results shaded to obstetrical practionnairOtherNot described
Receives: Procedure: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caesarean rate

    Demonstrate that achieving a so-called "engagement" ultrasound (mesurement of angle of progression) to reduce 30% cesarean rate in the second stage of labor in case of doubt about the level of commitment of fetal presentation. The primary endpoint is the rate of caesarean section.

    Measured: 2 years

Secondary outcomes (2)
  1. Numbers of haemorrhage

    Measured: 2 years

  2. perineal tears of 3 and 4th degree

    perineal wounds

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startJun 2013
  3. Primary completion9 Sep 2015
  4. Study completionOct 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02761304
Sponsor's protocol ID
2012-A01693-40
Other IDs
2012-53
Acronym
eng - echo
Status last verified
Oct 2021
First submitted
2 May 2016
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Haumonte JB, Blanc J, Castel P, Mace P, Auquier P, d'Ercole C, Bretelle F. Uncertain fetal head engagement: a prospective randomized controlled trial comparing digital exam with angle of progression. Am J Obstet Gynecol. 2022 Oct;227(4):625.e1-625.e8. doi: 10.1016/j.ajog.2022.04.018. Epub 2022 Apr 19.

    PubMed 35452654

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Caesarean Rate, run by Assistance Publique Hopitaux De Marseille at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caesarean rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02761304, which also lists 1 linked publication.

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 12 Oct 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in