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NCT04948021: MAF

Interest of the Kleihauer in Patients With Decreased Active Fetal Movements

Status unknown Last updated 7 March 2023
What this trial tests

trial in Fetal Movement Disorder in 1,683 participants. Status unknown.

Timeline
15 July 2021
Primary endpoint
15 August 2021
15 December 2023

Quick facts

Lead sponsorFondation Hôpital Saint-Joseph
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,683
Start date15 July 2021
Primary completion15 August 2021
Estimated completion15 December 2023
Sites1 location across France

Conditions studied

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, female only, with Fetal Movement Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04948021.

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