Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization

NCT07885592 | Recruiting Phase 2

• 1 other identifier: DMTH-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if giving intravenous immunoglobulin directly to the fetus during intrauterine transfusion can improve newborn outcomes in pregnancies affected by rhesus isoimmunization. Rhesus isoimmunization happens when a pregnant woman's immune system attacks her baby's red blood cells. This can cause severe anemia (low red blood cell levels) before birth. Doctors treat this condition with intrauterine transfusion, a procedure that gives blood to the fetus before birth. However, this treatment does not stop the immune attack. Many newborns still develop anemia and high bilirubin levels after birth and may need phototherapy or exchange transfusion. The main questions this study aims to answer are: Does adding fetal intravenous immunoglobulin increase the baby's blood count at birth? Does it lower the need for phototherapy or exchange transfusion after birth? Researchers will compare: Intrauterine transfusion with fetal intravenous immunoglobulin to Intrauterine transfusion alone to see if adding immunoglobulin improves newborn outcomes. Participants will:

• Undergo intrauterine transfusion as part of routine care
• Be randomly assigned to receive either standard transfusion alone or transfusion with added fetal immunoglobulin
• Be followed until delivery and during the newborn hospital stay The main outcome is the baby's blood count at birth. Researchers will also measure:
• How quickly the baby's blood count falls before birth
• Need for and duration of phototherapy
• Need for exchange transfusion or blood transfusions after birth
• Any procedure-related complications This study will help determine whether treating the immune process before birth can improve health outcomes for newborns affected by rhesus isoimmunization.

Conditions

Hemolytic Disease of the Newborn; Fetal Anemia; Rhesus Isoimmunization; Erythroblastosis Fetalis Due to RH Antibodies

Keywords

neonates; Rh isoimmunisation; fetal anemia; Intrauterine transfusion; Intravenous immunoglobulin; fetus; fetal administration

Outcome Measures

Primary Outcomes (1)

• Cord Blood Hematocrit at Birth

  Hematocrit measured from umbilical cord venous blood immediately after delivery, expressed as percentage of red blood cell volume.

  At birth (Day 1)

Secondary Outcomes (6)

• Rate of Post-Transfusion Decline in Fetal Hematocrit

  From first intrauterine transfusion until delivery

• Need for Phototherapy

  From birth until 28 days or discharge, whichever is earlier

• Duration of Phototherapy

  From birth until 28 days or discharge, whichever is earlier

• Need for Exchange Transfusion

  From birth until 28 days or discharge, whichever is earlier

• Number of Postnatal Packed Red Blood Cell Transfusions

  From birth until 28 days or discharge, whichever is earlier

Study Arms (2)

Standard Intrauterine Transfusion

ACTIVE COMPARATOR

Participants will undergo intrauterine transfusion using compatible packed red blood cells as per institutional protocol. No intravenous immunoglobulin will be administered to the fetus.

Procedure: Intrauterine Transfusion

Intrauterine Transfusion With Direct Fetal Intravenous Immunoglobulin

EXPERIMENTAL

Participants will undergo standard intrauterine transfusion followed by intravascular administration of intravenous immunoglobulin directly into the fetal circulation during the same procedure.

Procedure: Intrauterine Transfusion; Drug: Intravenous immunoglobulin (IVIG)

Interventions

Intrauterine Transfusion PROCEDURE

Ultrasound-guided intravascular transfusion of compatible packed red blood cells into the fetal circulation for treatment of fetal anemia.

Intrauterine Transfusion With Direct Fetal Intravenous Immunoglobulin; Standard Intrauterine Transfusion

Intravenous immunoglobulin (IVIG) DRUG

Intravenous immunoglobulin administered intravascularly into the fetal circulation during intrauterine transfusion.

Intrauterine Transfusion With Direct Fetal Intravenous Immunoglobulin

Eligibility Criteria

• Age: 20 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• Deka D, Sharma KA, Dadhwal V, Singh A, Kumar G, Vanamail P. Direct fetal intravenous immunoglobulin infusion as an adjunct to intrauterine fetal blood transfusion in rhesus-allommunized pregnancies: a pilot study. Fetal Diagn Ther. 2013;34(3):146-51. doi: 10.1159/000353236. Epub 2013 Aug 7.

  PMID: 23941890 BACKGROUND

MeSH Terms

Conditions

Erythroblastosis, Fetal

Interventions

Blood Transfusion, Intrauterine; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Fetal Therapies; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sourabh Dutta, MD, Ph.D

CONTACT

+91 172 2724053; sourabhdutta1@gmail.com

Vishnu Somakumar, MBBS, MD

CONTACT

+91 9791674117; vishnusomakumar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Newborn Unit, Department of Pediatrics

Model Details: Eligible mother-fetus dyads undergoing their first clinically indicated intrauterine transfusion will be randomized in a 1:2 allocation ratio to receive either standard intrauterine transfusion alone or intrauterine transfusion with adjunctive direct fetal intravenous immunoglobulin. Randomization will occur at the time of the first transfusion. Participants will remain in their assigned group for the duration of the study. There is no crossover between groups. All participants will receive standard antenatal and neonatal care as per institutional protocol.

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 21, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Access to de-identified data and supporting documents will be provided upon reasonable request to the principal investigator. Requests must include a methodologically sound proposal and will require execution of a data use agreement.

Locations

IN (1)