Interest of the Kleihauer in Patients With Decreased Active Fetal Movements

NCT04948021 | Unknown

• 1 other identifier: MAF
• Study Type: observational
• Target: 1,683
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Movement Disorder

Outcome Measures

Primary Outcomes (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.

  Statistical performance of tests (sensitivity, specificity, negative/positive predictive value and positive/negative likelihood ratio)

  Day 1

Secondary Outcomes (3)

• 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.

  Day 1

• To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.

  Day 1

• To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Inès BELAROUSSI

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: July 15, 2021
• Primary Completion: August 15, 2021
• Study Completion: December 15, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)