Health Condition 1: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Concept Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Cases or Controls: Pregnant women with gestational age of 20 weeks or greater (based on best obstetric estimate) with Singleton, viable pregnancy CASES only: Pregnant women admitted to a participating study facility with diagnosed pre-eclampsia, of any severity. CONTROLS only: Pregnant women attending or admitted to a participating study facility who are normotensive at time of screening and matched for Gestation age strata.
Exclusion criteria
Exclusion criteria: Cases or Controls: 1. Postpartum women 2. Women unable or unwilling to provide informed consent 3. Pregnant women less than 18 years old. Controls only: 1. Any known diagnosed hypertensive disorder of pregnancy preeclampsia, gestational hypertension, chronic hypertension 2. Women with suspected or diagnosed fetal growth restriction 3. Any known diagnosis of diabetes in pregnancy viz. type 1, type 2 or gestational diabetes mellitus 4. Any known retinal disease 5. Women with known moderate or severe anaemia 6. Known history of cardiovascular disease 7. Known history of chronic kidney disease 8. Known history of autoimmune conditions 9. Active smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central retinal artery equivalent (CRAE)Timepoint: At delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal measures (binary) presence of arteriole narrowing, tortuosity, segmental retinal artery vasospasm, papilledema, serous retinal detachments, cotton wool spots & retinal hemorrhagesTimepoint: At delivery;Biomarker test secondary outcomes viz. Hands-on time, Total turnaround time, Rate of invalid results, Device-related issues/malfunctionTimepoint: At delivery;Maternal health & process-of-care secondary outcomes viz. Pre-eclampsia (in controls), Maternal death, Severe hypertension, Placental abruptionTimepoint: At delivery;Severe maternal morbidity viz. Eclampsia, Cerebrovascular accident (stroke), Retinal detachment, Cortical blindness, Pulmonary oedema, Acute kidney injury, Liver capsule hematoma or rupture, Renal failure, Liver failure & HELLP syndromeTimepoint: At delivery;Any one or more severe maternal morbidities (composite outcome)Timepoint: At delivery;Intensive care unit (ICU) admission viz. Any admissions & for more than 24 hours o duration of ICU admission Intubation & mechanical ventilation (not for childbirth) Use of clinical interventions for pre-eclampsia or eclampsia viz. Anticonvulsant given (Magnesium Sulphate), Provider-initiated deliveryTimepoint: At delivery;Fetal/neonatal health & process-of-care outcomes which includes Stillbirth (fetal death from 22 weeks onward), Very early neonatal death (status at 24 hours), Perinatal death (any stillbirth or very early neonatal death), Gestational age at birth (weeks), Early preterm birth (less than 34 weeks gestation), Preterm birth (less than 37 weeks gestation), Birthweight measured in the first 24 hours after birth using a calibrated scale, Low birthweight (less than 2500g), Small-for-gestational-age, Admission to NICU or SNCU at 24 hours after birth, Very early neonatal death or admission to NICU or SNCU (composite) Timepoint: At delivery;Retinal measures vessel density & tortuosity Timepoint: At delivery | — |
Countries
India, South Africa
Contacts
Public ContactDr Manjunath S Somannavar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed