Fetal Movement DisorderMAFNCT04948021
Interest of the Kleihauer in Patients With Decreased Active Fetal Movements
An observational study of Fetal Movement Disorder, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Movement Disorder
- How many people
- 1,683 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Fetal Movement Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Comparison of the diagnostic performance of the Kleihauer test and peak systolic middle cerebral artery velocity for neonatal anemia
Measured: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Adverse neonatal outcomes
Measured: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Adverse obstetrical outcomes
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start15 Jul 2021
- Primary completion15 Aug 2021
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Movement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inès BELAROUSSI, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948021
- Sponsor's protocol ID
- MAF
- Acronym
- MAF
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Kleihauer in Patients With Decreased Active Fetal Movements
- ClinicalTrials.gov ID
- NCT04948021
- Acronym / sponsor ID
- MAF / MAF
- Conditions
- Fetal Movement Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,683 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Day 1
Statistical performance of tests (sensitivity, specificity, negative/positive predictive value and positive/negative likelihood ratio)
3 secondary outcomes
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.
Time frame: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Time frame: Day 1
To describe of obstetric outcomes for fetomaternal hemorrhage in patients consulting for decreased active fetal movements.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inès BELAROUSSI principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Movement Disorder, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.