Effect of giving immunoglobulin directly to the fetus during intrauterine blood transfusion on newborn outcomes in Rh incompatibility

Effect of direct fetal Intravenous Immunoglobulin administration during Intrauterine Transfusion on Neonatal outcomes in Rhesus Isoimmunised Pregnancies: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110057

Enrollment

Registered

2026-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O360- Maternal care for rhesus isoimmunization Health Condition 2: P550- Rh isoimmunization of newborn

Interventions

Intervention1: Intrauterine Transfusion With Direct Fetal Intravenous Immunoglobulin: Fetal intravenous immunoglobulin (IVIG) will be administered at a dose of 500 mg/kg of estimated fetal weight usin

Eligibility

Inclusion criteria

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 or legal guardian

Exclusion criteria

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 i.e chronic kidney disease stage 4 or 5 or acute renal failure 6. Multiple gestation pregnancy 7. Anticipated technical infeasibility of umbilical venous access

Design outcomes

Primary

Measure	Time frame
Cord Blood Hematocrit at Birth: Hematocrit measured from umbilical cord venous blood immediately after delivery, expressed as percentage of red blood cell volume.Timepoint: At birth	—

Secondary

Measure	Time frame
Rate of Post-Transfusion Decline in Fetal HematocritTimepoint: From first intrauterine transfusion until delivery;Need for PhototherapyTimepoint: From birth until hospital discharge;Duration of PhototherapyTimepoint: From birth until completion of phototherapy during initial hospitalization;Need for Exchange TransfusionTimepoint: From birth until hospital discharge;Number of Postnatal Packed Red Blood Cell TransfusionsTimepoint: From birth until hospital discharge;Procedure-Related Adverse EventsTimepoint: From first intrauterine transfusion until delivery	—

Measure

Time frame

Rate of Post-Transfusion Decline in Fetal HematocritTimepoint: From first intrauterine transfusion until delivery;Need for PhototherapyTimepoint: From birth until hospital discharge;Duration of PhototherapyTimepoint: From birth until completion of phototherapy during initial hospitalization;Need for Exchange TransfusionTimepoint: From birth until hospital discharge;Number of Postnatal Packed Red Blood Cell TransfusionsTimepoint: From birth until hospital discharge;Procedure-Related Adverse EventsTimepoint: From first intrauterine transfusion until delivery

—

Countries

India

Contacts

Public ContactVishnu Somakumar

Post Graduate Institute of Medical Education and Research, Chandigarh

vishnusomakumar@gmail.com9791674117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026