Role of Metformin in treatment of preclampsia

Phase 3

• Conditions: Health Condition 1: O140- Mild to moderate pre-eclampsia

• Registration Number: CTRI/2021/08/035925
• Lead Sponsor: JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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 <50Ã?109

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EONATAL-Prematurity, Birth APGAR score at 5 minute),Still birth, <br/ ><br>neonatal death <br/ ><br>MATERNAL-Eclampsia, Renal failure, CVA, HELLP, Death Left ventricular failure, Intubation, duration of mechanical ventilation, cardiovascular support <br/ ><br>Left ventricular failure, Intuba-tion, duration of mechanical ventilation, cardiovascular supportTimepoint: at metormin initiation and at delivery <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
eft ventricular failure, Intuba-tion, duration of mechanical ventilation, cardiovascular supportTimepoint: before delivery