Identification of Early Predictors of Fetomaternal Hemorrhage

This study has been completed.
Sponsor:
Collaborators:
New York Blood Center
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01232387
First received: October 29, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.

Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses pass from mother to baby through the placenta and only waste products pass from baby to mother through the placenta. Whole blood cells do not normally cross the placenta in significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant woman does not know this occurs. It is only discovered if a special blood test that is labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases, testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can cause the baby to become sick from anemia (low red blood cell count) is caused by large blood loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can result in death of the baby before or after birth, or significant illness in the newborn period. Short term problems for the baby include difficulty breathing, difficulty maintaining blood pressure, and difficulty providing oxygen to all parts of the body. This can cause multiple problems with the function of internal organs including the liver, kidneys, intestines, and brain. Babies who become sick from severe FMH can develop long-term problems including cerebral palsy (a lifelong problem with body movements) and/or mental retardation.

It is not known why some pregnancies are affected by FMH and others are not. It is thought that FMH may occur more frequently now than in the past, but no one knows why. If identified early, FMH is readily treatable by blood transfusion of the baby before or after birth and/or early delivery. Current laboratory testing for FMH is difficult and expensive. There is great need identify high risk patients early in pregnancy in order to treat the condition before the baby gets sick.

Approach: Five hundred women will be asked to participate in the study at the time they are admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study mothers will be tested for anemia. Mothers of anemic babies will donate blood for confirmation of FMH by established laboratory methods as well as for development of a new laboratory screening protocol. All mothers will provide medical, social, environmental, and full pregnancy history. Risk factors for FMH will be identified by statistical analysis of this information.


Condition
Fetomaternal Hemorrhage
Neonatal Anemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Identification of Early Predictors of Fetomaternal Hemorrhage And Development Of An Automated Screening Strategy For At-Risk Pregnancies

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Neonatal hematocrit [ Time Frame: Measured once within the first 72 hours of life ] [ Designated as safety issue: No ]
    Blood drawn in conjunction with the mandated New York State Newborn Screening Program specimen


Secondary Outcome Measures:
  • Sign of fetomaternal hemorrhage in maternal blood [ Time Frame: Blood drawn once upon admission for labor and delivery. ] [ Designated as safety issue: No ]
    Blood drawn in conjunction with clinically indicated antepartum labs


Biospecimen Retention:   Samples Without DNA

Whole blood, placenta


Enrollment: 39
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fetomaternal hemorrhage - Mothers
Mothers in Mother-baby pairs in which the testing for fetomaternal hemorrhage on the mother's blood demonstrates the presence of fetal cells.
Fetomaternal hemorrhage - Babies
Babies in Mother-baby pairs in which the testing for fetomaternal hemorrhage on the mother's blood demonstrates the presence of fetal cells.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A convenience sample of women admitted to the Mount Sinai Medical Center labor floor will be selected for this pilot study. Eligible women will be those admitted for term delivery (delivery between 37 0/7 and 41 6/7 weeks from the last menstrual period).

Criteria

Inclusion Criteria:

  • Women admitted for term delivery (delivery between 37 0/7 and 41 6/7 weeks from the last menstrual period) to the Mount Sinai Medical Center

Exclusion Criteria:

  • Women carrying fetuses with known fetal anomaly.
  • Women unable to complete the consent process due to likely precipitous delivery, severe labor discomfort, or fetal distress requiring immediate intervention.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232387

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
New York Blood Center
Investigators
Principal Investigator: Annemarie Stroustrup, MD, MPH Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01232387     History of Changes
Other Study ID Numbers: 10-0920, KL2RR029885
Study First Received: October 29, 2010
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Fetomaternal hemorrhage
neonatal anemia
perinatal epidemiology
Kleihauer-Betke
flow cytometry

Additional relevant MeSH terms:
Hemorrhage
Fetomaternal Transfusion
Anemia, Neonatal
Pathologic Processes
Anemia
Hematologic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 20, 2014