Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Jubilee Mission Medical College and Research Institute