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Correlation of a blood test done in first third of pregnancy for 4 markers with outcome of the mother and the baby

First trimester quadruple test and its correlation with fetomaternal outcome; A prospective study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028754
Enrollment
500
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O359- Maternal care for (suspected) fetal abnormality and damage, unspecified

Interventions

Intervention1: First trimester quadruple test by venous blood sample: Blood sample will be taken from pregnant woman fulfilling inclusion criteria between 11 to 13.6 weeks of pregnancy. results will b

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal women within singleton pregnancy 11to 13 weeks gestation at the time of recruitment

Exclusion criteria

Exclusion criteria: 1. Pregnancies with multiple gestations, vanishing twins 2. Known maternal liver tumors, germ cell tumors, and other maternal malignancy that could affect msAFP levels. 3. Donor oocyte IVF conceptions 4. Chronic hypertension, diabetes, Chronic kidney disease

Design outcomes

Primary

MeasureTime frame
1. To determine the detection rate for aneupoidies with the first trimester quadruple test 1. To find out the association between individual markers of first trimester quadruple test with the development of preeclampsia, spontaneous miscarriage, preterm delivery and placental abruption Timepoint: 1.5 years

Secondary

MeasureTime frame
1. To compare the diagnostic measures such as sensitivity, specificity, PPV, NPV and likelihood ratio of screening test vs confirmatorty test for aneuploidies. 2. To find out the association between individual markers of first trimester quadruple test with congenital abnormalities, fetal growth restriction , fetal demise. Timepoint: 1.5 years

Countries

India

Contacts

Public ContactRinchen Zangmo

All India Institute of Medical Sciences, New Delhi

rinchhen.zn@gmail.com09910557436

Outcome results

None listed

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