A Randomized controlled trial to compare the effectiveness of Metformin in prolonging period of gestation in Pre-eclampsia without severe features to standard treatment

A Randomized controlled trial to compare the effectiveness of Metformin in prolonging period of gestation in Pre-eclampsia without severe features to standard treatment - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100256

Enrollment

Registered

2026-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: METFORMIN: Depending on block randomization, patient with pre-eclampsia without severe features alloted will be given 500mg of oral extended release metformin daily three times a day un

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with age more than or equal to 18 years of age. 2. Women diagnosed with pre-eclampsia without severe features with period of gestation more than 28 weeks.

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancies 2. Women with chronic hypertension, gestational hypertension. 3. Women with gestational diabetes mellitus. 4. Women with contraindications to metformin (Renal dysfunction, hypersensitivity to metformin, Acute or chronic metabolic acidosis, Impaired hepatic function) 5. Women with pre-existing conditions that could interfere with the study outcomes (e.g., severe renal impairment, liver disease). 6. Women who are already on medications that could affect the study outcomes (glyburide, furosemide or cationic drugs)

Design outcomes

Primary

Measure	Time frame
To compare the number of days prolonged in metformin group versus group on standardised treatment protocol in patients with pre-eclampsia without severe featuresTimepoint: The period of gestation at time of termination of pregnancy will be considered	—

Secondary

Measure	Time frame
1. To investigate the neonatal outcomes of infants born to mothers treated with metformin in terms of birth weight, RDS, hypoglycemia, NICU admissions & neonatal death compared to mothers in the control group. 2. To assess for any other side effects like diarrhea, nausea, vomiting, gastritis, lactic acidosis symptoms in metformin treated mothers.Timepoint: 1. The neonatal outcomes will be assesed at birth. 2. Side effects will be assed during pregnancy period when patient is being treated with metformin	—

Measure

Time frame

1. To investigate the neonatal outcomes of infants born to mothers treated with metformin in terms of birth weight, RDS, hypoglycemia, NICU admissions & neonatal death compared to mothers in the control group. 2. To assess for any other side effects like diarrhea, nausea, vomiting, gastritis, lactic acidosis symptoms in metformin treated mothers.Timepoint: 1. The neonatal outcomes will be assesed at birth. 2. Side effects will be assed during pregnancy period when patient is being treated with metformin

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Countries

India

Contacts

Public ContactDr Shinde Manali Madhukar

Shri B.M Patil Medical college Hospital and Research centre

neelamma.patil@bldedu.ac.in9845068074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026