Health Condition 1: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dr Sharmila Jalgaonkar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant patients classified as moderate to high risk for pre-eclampsia at 12-16 weeks of gestation according to FOGSI guidelines, to be started on aspirin prophylaxis by the attending obstetrician in the antenatal outpatient clinic. 2. Pregnant patients categorized as low risk of pre eclampsia at 12-16 weeks of gestation according to FOGSI guidelines by the attending obstetrician and not started on aspirin prophylaxis 3. Patients with age above 18 years 4. Intra uterine pregnancy 5. Patients planning to have delivery in KEM Hospital
Exclusion criteria
Exclusion criteria: 1. Patients not willing to give informed consent 2. Patients admitted in IPD and emergency department for causes not related to pregnancy 3. Chronic Kidney Disease 4. Contraindication to Aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentration of NfL in moderate to high risk patients and low risk patients of pre-eclampsiaTimepoint: 1. Baseline Value (Visit 0)- 12-16 weeks 2. Visit 1- 24-26 weeks 3. Visit 2- 32-34 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Variables: Observe patients for the development of- Maternal Clinical Outcomes: 1. Gestational hypertension 2. Pre-eclampsia 3. Eclampsia 4. Abruptio Placenta Fetal : 1. Gestational age at termination of pregnancy 2. Intrauterine fetal demise / stillbirth Neonatal- 1. Birth weight 2. Neonatal ICU admission due to complicationsTimepoint: 1. Baseline visit (Visit 0)- 12-16 weeks 2. Visit 1- 24-26 weeks 3. Visit 2- 32-34 weeks 4. Visit 3-Delivery 5. Visit 4-One month post partum;Biochemical variables : 1. Proteinuria 2. HELLP syndrome (according to Tennessee classification system)Timepoint: 1. Baseline visit (Visit 0)- 12-16 weeks 2. Visit 1- 24-26 weeks 3. Visit 2- 32-34 weeks 4. Visit 3- Delivery 5. Visit 4- One month post partum;Radiological variables: Maternal (uterine artery doppler): 1. Pulsatility index 2. Resistance index 3. Systolic diastolic ratio 4. Presence of diastolic notch beyond 24 weeks Fetal: Intra uterine growth restriction Timepoint: 1. Baseline values( Visit 0)- 12-16 weeks 2. Visit 1- 24-26 weeks 3. Visit 2- 32-34 weeks 4. Visit 3- Delivery;Correlation between Serum NfL levels with maternal clinical outcomes, fetal clinical outcomes, neonatal clinical outcomes and radiological parameters in low risk and moderate to high risk groupsTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Sharmila Jalgaonkar
Seth GS Medical College and KEM Hospital
Outcome results
None listed