Health Condition 1: O140- Mild to moderate pre-eclampsia
Conditions
Interventions
Intervention1: Treatment arm: Each woman will receive 500 mg of metformin 3 times daily. Patient will continue to receive other standard care including antihypertensive medications.
Control Intervent
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: All parous women more than 18-45 years with a diagnosis of one of the following: a. Pre-eclampsia b. Preexisting hypertension with evidence of pre-eclampsia c. Unclassified proteinuric hypertension Satisfying all these criteria d. Gestational age between 20 weeks and 36 weeks e. Singleton pregnancy f. The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48â??hours g. The managing clinician and neonatologist believe that the fetus could potentially be delivered in a viable condition h. No suspicions of a major fetal anomaly or malformations. i. The patient will be admitted to the hospital for expectant management and standardized care
Exclusion criteria
Exclusion criteria: Established fetal compromise that necessitates delivery Eclampsia Cerebrovascular event Posterior reversible encephalopathy syndrome Severe renal impairment, defined as a creatinine level >=125 μmol/l or a need for dialysis Pulmonary oedema Left-sided heart failure Disseminated intravascular coagulation Platelet count Haemolysis, elevated liver enzymes and low platelets syn-drome Liver transaminases >500 IU/L Liver hematoma or rupture Ascites ( >500 ml) Contraindications or a hypersensitivity reaction to the use of metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NEONATAL-Prematurity, Birth APGAR score at 5 minute),Still birth, neonatal death MATERNAL-Eclampsia, Renal failure, CVA, HELLP, Death Left ventricular failure, Intubation, duration of mechanical ventilation, cardiovascular support Left ventricular failure, Intuba-tion, duration of mechanical ventilation, cardiovascular supportTimepoint: at metormin initiation and at delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular failure, Intuba-tion, duration of mechanical ventilation, cardiovascular supportTimepoint: before delivery | — |
Countries
India
Contacts
Public ContactNivedita
JIPMER, Puducherry
Outcome results
None listed