IVIG given to the fetus during intrauterine transfusion for Rh isoimmunization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial explores adding fetal intravenous immunoglobulin to the standard intrauterine transfusion for pregnancies complicated by Rh isoimmunization and fetal anemia. Researchers will compare outcomes of intrauterine transfusion with IVIG to the usual approach, focusing on newborn blood counts at birth and the need for postnatal phototherapy or exchange transfusions. The trial enrolls Rh-isoimmunized mother-fetus pairs at 20 weeks gestation or later who require a first clinically indicated intrauterine transfusion. Eligible participants must meet safety criteria and provide informed consent. The intervention aims to attenuate ongoing immune-mediated hemolysis before birth to reduce neonatal treatment burden.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Rh isoimmunized mother-fetus dyads undergoing first clinically indicated intrauterine transfusion
2. Gestational age 20 weeks or more at the time of first intrauterine transfusion
3. Written informed consent obtained from parent(s) or legal guardian

Exclusion Criteria:

1. Major fetal structural anomaly or chromosomal abnormality
2. Maternal contraindication to intrauterine transfusion
3. Known immunoglobulin A deficiency with anti-immunoglobulin A antibodies
4. Previous anaphylaxis to intravenous immunoglobulin
5. Severe maternal renal impairment (chronic kidney disease stage 4 or 5 or acute renal failure)
6. Multiple gestation pregnancy
7. Anticipated technical infeasibility of umbilical venous access

Where it's running

• Pgimer
  Chandigarh, Chandigarh, India Recruiting

Study contacts

• Study coordinator: Sourabh Dutta, MD, Ph.D
• Email: sourabhdutta1@gmail.com
• Phone: +91 172 2724053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.