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Circulating SPINT1 –A biomarker of pregnancies with poor placental function and foetal growth restriction

Circulating serine peptidase inhibitor, Kunitz type 1(SPINT1) –A biomarker of pregnancies with poor placental function and fetal growth restriction - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/057138
Enrollment
77
Registered
2023-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: O099- Supervision of high risk pregnancy, unspecified

Interventions

Intervention1: Heamoglobin analysis and Elisa tests: Blood samples (2 ml) will be collected from pregnant ladies with guaranteed fetal viability by USG tests between 27th – 36th weeks gestation during

Sponsors

FATHER MULLER RESEARCH CENTER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All pregnant ladies above 18 years of age without past medical complications and with obstetric history of anaemia, hypertensive disorders of pregnancy (Eclampsia and preeclampsia), diabetes, maternal infections such as rubella, active tuberculosis, malaria, pregnancies assisted by use of ovulation induction drugs or in-vitro fertilization, gestational diabetes mellitus will be regarded as maternal complications. Fetal complications include samples with oligohydramnios, fetal distress, fetal growth retardation, premature rupture of membranes, placental abruption. Samples with above mentioned maternal and fetal complications will be included for the study.

Exclusion criteria

Exclusion criteria: Pregnancies with aneuploidy, congenital malformations, major fetal abnormalities and genetic disorders will be excluded.

Design outcomes

Primary

MeasureTime frame
Outcome from this study will be useful to identify the maternal biomarker as an indication for IUGR as well as still birth & to take precautionary methods to avoid the risk & cause of sameTimepoint: SRB and ethics approvals, Procurement of consumables -1-6 months. Sample collection and SPINT 1 analysis-1-18 months Data compilation, analysis and interpretation, publications-19-24 months

Secondary

MeasureTime frame
Study results can highlight unique expression profiles of SPINT 1, & identify potential candidate as predictive markers for IUGR & still births which can be utilized in future bedside tests. The ability to identify those women at risk of early in pregnancy & frequent USG’s can be avoided for the potential candidates. The study results would allow earlier clinical interventions, such as administration of low dose aspirin, focused monitoring of fetal growth, avoidance of drugs/smoking, control of maternal disorders (eg. hypertension), & adjustments to maternal lifestyle & diet, to improve the intrauterine environment & therefore attenuate the causes of impaired growth.Timepoint: SRB & ethics approvals, Procurement of consumables -1-6 months. Sample collection & SPINT 1 analysis-1-18 months Data compilation, analysis & interpretation, publications-19-24 months

Countries

India

Contacts

Public ContactDR DIVIA PAUL A

FATHER MULLER MEDICAL COLLEGE

divia_manoj@fathermuller.in08075789347

Outcome results

None listed

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