The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.
Study Type
OBSERVATIONAL
Enrollment
175
No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.
Riley Children s Hospital
Indianapolis, Indiana, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGOregon Health And Science University
Portland, Oregon, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGThe Royal Women's Hospital
Parkville, Australia
RECRUITINGMater Misericordiae Ltd
South Brisbane, Australia
RECRUITINGInterdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany
RECRUITINGMangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy
RECRUITINGFondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
RECRUITINGBirmingham Women's Hospital
Birmingham, United Kingdom
RECRUITINGPercentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period
Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be reported. Hydrops fetalis is defined as the presence of greater than or equal to (\>=) 2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater than \[\>\] 5 millimeter \[mm\]). Post-menstrual age (PMA) is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).
Time frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Number of participants in each HDFN severity index category will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. HDFN requiring phototherapy will be classified in this category.
Time frame: Through 4 weeks of age or 41 weeks PMA, whichever is later
Time to First Occurrence of IUT or Hydrops Fetalis
Time to first occurrence of IUT or hydrops fetalis will be reported.
Time frame: From conception to delivery date (up to maximum of 42 weeks)
Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates
The mNMMI will be assessed with the following categories: fatal: neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category.
Time frame: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUTs Received During the Pregnancy
Number of IUT's received during the pregnancy will be reported.
Time frame: From conception to delivery date (up to maximum of 42 weeks)
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