An observational study in Fetal Movement Disorder, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
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.
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.
320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.
This study's enrollment of 1,683 is above the median of 80 across 132 observational studies indexed under Movement Disorders.
Browse Movement Disorders studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will be performed on data from patients referred for decreased active fetal movements between 01/01/2015 and 12/31/2020, approximately 1000 patients in total.
Exclusion Criteria:
To evaluate the diagnostic performance of each of the two tests: Kleihauer test / Doppler + fetal heart rate for the diagnosis of neonatal anemia (by cord blood sampling) among patients presenting with decreased active fetal movements.
Statistical performance of tests (sensitivity, specificity, negative/positive predictive value and positive/negative likelihood ratio)
Time frame: Day 1
To evaluate the diagnostic performance of the middle cerebral artery Doppler + fetal heart rate pair in comparison with the Kleihauer test for the diagnosis of neonatal anemia.
Comparison of the diagnostic performance of the Kleihauer test and peak systolic middle cerebral artery velocity for neonatal anemia
Time frame: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Adverse neonatal outcomes
Time frame: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Adverse obstetrical outcomes
Time frame: Day 1
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondation Hôpital Saint-Joseph