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finding out the normal value of bleeding and clotting factors using ROTEM machine in pregnant woman

Defining a normal reference range for rotational thromboelastometry (ROTEM) in healthy obstetric population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/052143
Enrollment
600
Registered
2023-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Control Intervention1: nil: nil

Sponsors

Dr Usha Shenoy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with singleton pregnancies will be recruited from the obstetric admission clinic if they were booked for an elective caesarean delivery at term ( >37 weeks’ gestation); aged 18– 45 years; of body mass index (BMI) 18.5–30 kg/m2; and having an uncomplicated pregnancy.

Exclusion criteria

Exclusion criteria: 1. Gestational hypertension, preeclampsia and HELLP (haemolysis, elevated liver enzymes and low platelet count) syndrome 2. Gestational diabetes mellitus 3. Anaemia 4. Gestational thrombocytopenia 5. Cholestasis of pregnancy 6. Antepartum haemorrhage 7. Factor V Leiden deficiency, antiphospholipid syndrome, haemochromatosis, thalassaemia and human immunodeficiency virus 8. Women on anticoagulant drugs for thromboembolism or on aspirin

Design outcomes

Primary

MeasureTime frame
1.Determining reference range of ROTEM parameters during the third trimester of normal pregnancy. 2.Determining baseline ROTEM parameters in healthy young females in central Kerala. 3.Correlating ROTEM data with simultaneous blood profile. Timepoint: 1.Determining ROTEM parameters during the third trimester of normal pregnancy on admission to labour room(0 day) 2.Correlating ROTEM data with simultaneous blood profile taken at labour room on admission( 0 day)

Secondary

MeasureTime frame
1. Developing a specific ROTEM based transfusion algorithm to manage major bleeding in pregnancy & validating the above to suit local conditions. 2. Several potential areas for use in obstetrics have been suggested, including detecting hypercoagulability, prediction of thromboembolism, assessment of coagulopathy in gestational diabetes, antiphospholipid syndrome, recurrent pregnancy loss, preeclampsia, and HELLP (Haemolysis, Elevated Liver enzymes and Low Platelet) syndrome. Timepoint: 1. Developing a specific ROTEM based transfusion algorithm to manage major bleeding in pregnancy & validating the above to suit local conditions. (at the end of 2 years)

Countries

India

Contacts

Public ContactDr Usha Shenoy

Jubilee Mission Medical College and Research Institute

rssuss@gmail.com9446575724

Outcome results

None listed

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