Interest of the Kleihauer in Patients With Decreased Active Fetal Movements (NCT04948021) | Clinical Trial Compass
UnknownNot Applicable
Interest of the Kleihauer in Patients With Decreased Active Fetal Movements
France1,683 participantsStarted 2021-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients whose age ≥ 18 years
* French speaking patients
* Consultation for decreased active fetal movements
* Singleton pregnancies
* Gestational age between 24 weeks of amenorrhea and 41 weeks of amenorrhea +5 days
Exclusion Criteria:
* Patients under guardianship or curatorship
* Patients deprived of liberty
* Patients under court protection
* Patients who object to the use of their data for this research
* Fetal or neonatal anemia of documented cause other than fetomaternal hemorrhage
* Consultation for metrorrhagia
* Consultation for Abdominal Trauma
* Consultation for external maneuver version
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.