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.
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.
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 group | Role | What they receive |
|---|---|---|
| ultrasound results given to obstetrical practionnair | Experimental | Not described Receives: Procedure: Ultrasound |
| ultrasound results shaded to obstetrical practionnair | Other | Not described Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Numbers of haemorrhage
Measured: 2 years
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.
- First posted4 May 2016 (estimated)
- Study startJun 2013
- Primary completion9 Sep 2015
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean RateStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, ASSISTANCE PUBLIQUE DE MARSEILLE
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02761304
- Acronym / sponsor ID
- eng - echo / 2012-A01693-40
- Conditions
- Caesarean Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 9 Sep 2015 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 4 May 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound results given to obstetrical practionnair | Experimental | Procedure: Ultrasound |
| ultrasound results shaded to obstetrical practionnair | Other | Procedure: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- Abnormal fetal heart rate or suspected fetal acidosis on a scale pH
- No maternal indication for vaginal delivery or instrumental delivery
- No fetal indication for instrumental delivery (suspected fetal thrombocytopenia)
- Other than fetal cephalic presentations
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 |
|---|---|---|
| Ultrasound | Procedure or surgery | ultrasound results given to obstetrical practionnair, ultrasound results shaded to obstetrical practionnair |
Primary outcome
Caesarean rate
Time frame: 2 years
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.
2 secondary outcomes
Numbers of haemorrhage
Time frame: 2 years
perineal tears of 3 and 4th degree
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 35452654Haumonte 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.
- Individual participant dataSharing planned: No
Related trials for Caesarean Rate
Recruiting
Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
Obstetrics: Elective Caesarean Delivery
Not yet recruiting
Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate
Caesarean Section, Pregnant Women
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.
Urielle DESALBRES study director
ASSISTANCE PUBLIQUE DE MARSEILLE
1 site in 1 country: see every site and its status.
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.