Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04948021 |
| Other study ID # |
MAF |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2021 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Fetomaternal hemorrhage is the passage of fetal red blood cells through the placental barrier
into the maternal blood. This phenomenon frequently occurs in the third trimester for small
quantities of blood < 0.5 ml and is without fetal consequences in rhesus positive patients.
This hemorrhage can sometimes be more important and be the cause of fetal anemia or even
fetal death in utero.
Diagnostic confirmation is biological and is performed using the Kleihauer test. It is based
on the identification by the biologist of fetal cells circulating in the maternal blood by
counting acid-fast fetal cells under the microscope. It is therefore a time-consuming
examination with significant inter- and intra-observer variability.
The clinical sign most often reported in the literature, and the earliest sign that may
suggest fetomaternal hemorrhage complicated by fetal anemia, is a decrease in active fetal
movements. However, this is an aspecific sign and is one of the most common reasons for
consultation in obstetric emergencies.
Description:
There are other arguments in favor of complicated fetomaternal hemorrhage: The fetal heart
rate is often altered in severe fetal anemia, with sinusoidal rhythm being pathognomonic but
uncommon. A slightly oscillating rhythm or variable decelerations are also found.
On ultrasound, peak systolic middle cerebral artery velocity > 1.5 MoM correlates with fetal
anemia early before the appearance of hydrops.
Some studies show that peak systolic middle cerebral artery velocity correlates better with
neonatal hemoglobin than the Kleihauer test, for which no threshold has been found to predict
an unfavorable outcome. Thus, even if the Kleihauer test is positive, the positive predictive
value for fetal anemia is low. The detection of a small amount of fetomaternal hemorrhage by
Kleihauer in the absence of evidence of anemia could even be deleterious, potentially leading
to an excess of additional investigations and obstetrical interventions.
The interest of systematically performing the Kleihauer test to search for fetomaternal
hemorrhage is uncertain at this time because of the development and the undeniable
contribution of ultrasound. However, in France, it is still carried out in most maternity
wards in the absence of recommendations for any decrease in active fetal movements.
Only one article has looked specifically at fetomaternal hemorrhage in a group of patients
consulting for a decrease in active fetal movements, calling into question its interest.
