Identification of Early Predictors of Fetomaternal Hemorrhage

NCT01232387 | Completed

• 2 other identifiers: 10-0920KL2RR029885
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetomaternal Hemorrhage; Neonatal Anemia

Keywords

Fetomaternal hemorrhage; neonatal anemia; perinatal epidemiology; Kleihauer-Betke; flow cytometry

Outcome Measures

Primary Outcomes (1)

• Neonatal hematocrit

  Blood drawn in conjunction with the mandated New York State Newborn Screening Program specimen

  Measured once within the first 72 hours of life

Secondary Outcomes (1)

• Sign of fetomaternal hemorrhage in maternal blood

  Blood drawn once upon admission for labor and delivery.

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Center for Research Resources (NCRR): collaborator
• New York Blood Center: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (15)

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  PMID: 10685227 BACKGROUND

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  PMID: 8127519 BACKGROUND

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  PMID: 9178311 BACKGROUND

• Rubod C, Deruelle P, Le Goueff F, Tunez V, Fournier M, Subtil D. Long-term prognosis for infants after massive fetomaternal hemorrhage. Obstet Gynecol. 2007 Aug;110(2 Pt 1):256-60. doi: 10.1097/01.AOG.0000271212.66040.70.

  PMID: 17666598 BACKGROUND

• Laube DW, Schauberger CW. Fetomaternal bleeding as a cause for "unexplained" fetal death. Obstet Gynecol. 1982 Nov;60(5):649-51.

  PMID: 7145257 BACKGROUND

• Kecskes Z. Large fetomaternal hemorrhage: clinical presentation and outcome. J Matern Fetal Neonatal Med. 2003 Feb;13(2):128-32. doi: 10.1080/jmf.13.2.128.132.

  PMID: 12735414 BACKGROUND

• David M, Smidt J, Chen FC, Stein U, Dudenhausen JW. Risk factors for fetal-to-maternal transfusion in Rh D-negative women--results of a prospective study on 942 pregnant women. J Perinat Med. 2004;32(3):254-7. doi: 10.1515/JPM.2004.047.

  PMID: 15188800 BACKGROUND

• Fischer RL, Kuhlman K, Grover J, Montgomery O, Wapner RJ. Chronic, massive fetomaternal hemorrhage treated with repeated fetal intravascular transfusions. Am J Obstet Gynecol. 1990 Jan;162(1):203-4. doi: 10.1016/0002-9378(90)90850-7.

  PMID: 2301494 BACKGROUND

• Rubod C, Houfflin V, Belot F, Ardiet E, Dufour P, Subtil D, Deruelle P. Successful in utero treatment of chronic and massive fetomaternal hemorrhage with fetal hydrops. Fetal Diagn Ther. 2006;21(5):410-3. doi: 10.1159/000093881.

  PMID: 16912488 BACKGROUND

• Brennand J, Cameron A. Fetal anaemia: diagnosis and management. Best Pract Res Clin Obstet Gynaecol. 2008 Feb;22(1):15-29. doi: 10.1016/j.bpobgyn.2007.08.005. Epub 2007 Oct 1.

  PMID: 17904904 BACKGROUND

• KLEIHAUER E, BRAUN H, BETKE K. [Demonstration of fetal hemoglobin in erythrocytes of a blood smear]. Klin Wochenschr. 1957 Jun 15;35(12):637-8. doi: 10.1007/BF01481043. No abstract available. German.

  PMID: 13450287 BACKGROUND

• Pelikan DM, Scherjon SA, Mesker WE, de Groot-Swings GM, Brouwer-Mandema GG, Tanke HJ, Kanhai HH. Quantification of fetomaternal hemorrhage: a comparative study of the manual and automated microscopic Kleihauer-Betke tests and flow cytometry in clinical samples. Am J Obstet Gynecol. 2004 Aug;191(2):551-7. doi: 10.1016/j.ajog.2004.01.007.

  PMID: 15343236 BACKGROUND

• Davis BH, Olsen S, Bigelow NC, Chen JC. Detection of fetal red cells in fetomaternal hemorrhage using a fetal hemoglobin monoclonal antibody by flow cytometry. Transfusion. 1998 Aug;38(8):749-56. doi: 10.1046/j.1537-2995.1998.38898375514.x.

  PMID: 9709783 BACKGROUND

• Scholz C, Kachler A, Hermann C, Weissenbacher T, Toth B, Friese K, Kainer F. Flowcytometric assessment of fetomaternal hemorrhage during external cephalic version at term. J Perinat Med. 2009;37(4):334-7. doi: 10.1515/JPM.2009.063.

  PMID: 19290855 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, placenta

MeSH Terms

Conditions

Fetomaternal Transfusion; Anemia, Neonatal

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Annemarie Stroustrup, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2013
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

US (1)