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CompletedNCT02761304eng - echoUpdated Oct 12, 2021

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

An interventional study of Ultrasound in Caesarean Rate, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Caesarean Rate
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    ultrasound results given to obstetrical practionnair

    Procedure: Ultrasound

  • Other
    ultrasound results shaded to obstetrical practionnair

    Procedure: Ultrasound

Interventions

  • ProcedureUltrasound
06

What researchers measure

Primary outcomes

  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.

    Time frame: 2 years

Secondary outcomes

  1. Numbers of haemorrhage

    Time frame: 2 years

  2. perineal tears of 3 and 4th degree

    perineal wounds

    Time frame: 2 years

Other outcomes

  1. Apgar scoring

    Side effects with short term fetal complication

    Time frame: 2 years

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Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02761304
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
May 4, 2016
Start date
Jun 2013
Primary completion
Sep 9, 2015
Completion
Oct 2021
Last update
Oct 12, 2021

Study contacts

Urielle DESALBRES
study director · ASSISTANCE PUBLIQUE DE MARSEILLE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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