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Role of IVIG in recurrent pregnancy loss

Role of Intravenous immunoglobulin in improving pregnancy outcome in women with unexplained recurrent pregnancy loss Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068800
Enrollment
124
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history Health Condition 2: O092- Supervision of pregnancy with other poor reproductive or obstetric history Health Condition 3: O092- Supervision of pregnancy with other poor reproductive or obstetric history

Interventions

Intervention1: Group 1 (IVIG group): Patients randomised in group 1 (IVIG group) will receive IVIG along with routine care. The active drug used was 5% formulation of intact type human immunoglobulin

Sponsors

All india Institute of Medical Sciences, New delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 18-40 years 2) Pregnant women with 3 or more unexplained pregnancy losses 3) Primary or secondary RPL

Exclusion criteria

Exclusion criteria: 1) Previous biochemical pregnancy loss will not be included 2) Fetus with congenital anomaly 3) Any uterine anomaly 4) Autoimmune disorder 5) Thyroid dysfunction 6) APLA 7) Thrombophilia 8) Insulin dependent DM 9) IVF pregnancy 10) Total IgA deficiency 11) Parental chromosomal abnormality 12) Not willing to participate

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the ongoing pregnancy rate at 22 weeks of gestation. Secondary outcome will be to compare live birth rate in both the groups and risk of fetal growth restriction (FGR) and preterm delivery (PTB) in intervention groupTimepoint: Till delivery

Secondary

MeasureTime frame
Secondary outcome will be to compare live birth rate in both the groups and risk of fetal growth restriction (FGR) and preterm delivery (PTB) in intervention groupTimepoint: Till delivery

Countries

India

Contacts

Public ContactDr Neha Varun

All India Institute of medical sciences, New Delhi

drneha.ucms@gmail.com9873884869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026