A Historical Cohort, Multicenter Study to Characterize the Management, Clinical Course, and Outcomes of Pregnancies in Participants Who Have Experienced a Pregnancy With Severe HDFN
H
Hiba Mustafa, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this study is to better understand how pregnancies affected by severe Hemolytic Disease of the Fetus and Newborn (HDFN) are managed and what outcomes result from different treatment approaches. By analyzing past pregnancies from 2006 to 2023, this study aims to identify trends, risks, and factors that influence the health of both the mother and baby. The findings may help improve future care and decision-making for pregnant individuals facing similar conditions.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be identified through retrospective medical record review from 2006–2023 to determine eligibility. Eligible subjects will be contacted via phone directly by the research team and invited to participate in the survey.
Detailed description of study
What will happen during the study?
- A one-time telephone survey will be conducted via phone with eligible participants to collect information on reproductive decisions following an HDFN-affected pregnancy.
- The survey is expected to take approximately 20–30 minutes.
- Collected Data: Maternal experiences, decision-making regarding future pregnancies, and psychosocial impact of HDFN.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hemolytic Disease of the Fetus and Newborn, HDFN, Riley
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria:
- Pregnant individuals with a history of Hemolytic Disease of the Fetus and Newborn (HDFN).
- Medical records from 2006–2023 with relevant maternal-fetal data.
- Availability of key clinical data such as antibody titers, intrauterine transfusions, and neonatal outcomes.
- Willingness to participate in the telephone survey (if applicable).
Updated on
07 Apr 2025.
Study ID: OBGYN-JANSSEN-HDFN, 26202
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