Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06322732 |
| Other study ID # |
APHP191125 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Gilles KAYEM, MD, PhD |
| Phone |
+33 1 44 73 51 20 |
| Email |
gilles.kayem[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to identify and analyze suboptimal perinatal
(obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or
death of the newborn at or near term.
Perinatal asphyxia is a serious and often unexpected pathology, requiring urgent
multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of
technical expertise and care coordination. Because of its rarity and complexity, it may be
subject to suboptimal care.
The aim of this study is to provide feedback within the center itself, coupled in 1/3 of
cases with a confidential investigation into the search for and understanding of suboptimal
care.
Primary endpoint:
Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic
encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia.
Description:
Perinatal asphyxia at term is a severe pathology that can lead to peripartum death or a birth
in vital distress with neurological damage known as anoxic-ischemic encephalopathy (AIE),
representing 1.6 per thousand births. In this unexpected and urgent situation, obstetric and
neonatal management will have a decisive impact on the neonatal and neurological prognosis of
the newborn. Despite a significant improvement in prognosis in recent years, it remains
severe, with an estimated risk of death of 15-20% and moderate to severe disability in
survivors of 30%.
The management of severe perinatal asphyxia combines a large number of risks that have been
identified as providing suboptimal care in a patient deemed to be vulnerable. Batlle showed
in an obstetrical clinical audit, in the form of a peer review in France in 2010, that half
the cases of per-partum asphyxia audited were considered "possibly or certainly avoidable".
Similar results were found in studies in Denmark and Sweden. Chevallier et al in France
showed that around 35% of newborns requiring hypothermia did not receive it in accordance
with French recommendations. The aim of analyzing this sub-optimal care is to identify the
systematic factors that led to the error, and to suggest solutions to avoid similar cases in
the future.
Corrective action has been taken on the basis of these studies: "Every case of asphyxia could
be used as an example for learning" is the title of an article proposing recommendations for
obstetric clinical practice based on audits of perinatal asphyxia cases. In Queensland, the
implementation of a national education program on fetal heart rate reading has led to a
significant reduction in the incidence of AIS from 250 to 160 events/100,000 live births. In
the UK, a pragmatic approach has been initiated to improve prognosis in the context of
perinatal asphyxia. "Each Baby Count" https://www.rcog.org.uk/eachbabycounts, is a national
platform recording every case of perinatal asphyxia and AIE, and collecting data on
sub-optimal care. This work will help to improve the quality of care both locally and
nationally.
These experiences suggest that the identification of sub-optimal obstetric and neonatal care
through a voluntary approach by the centers can lead to improved prevention and management.
In France, serious adverse events are analyzed during morbidity and mortality reviews, which
remain internal to the facilities and have limited impact at national level. The aim of this
study is to describe cases of death or HIE, to analyze the risk factors and to assess the
optimality of care in both obstetrics and pediatrics.
