Results seen in pregnant women treated with metformin in early stages of pregnancy when glucose levels tested 2 hours after meal are raised above normal level

Outcome of women with early gestational glucose intolerance treated with medical nutrition therapy and metformin versus only medical nutrition therapy randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071360

Enrollment

220

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Metformin: Metformin 250mg perorally twice daily is given along with medical nutrition therapy in women with early gestational glucose intolerance from 8 weeks of pregnancy for 29weeks

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with period of gestation less than 9 week having gestational glucose intolerance with PPBS more than 110 mg/dl

Exclusion criteria

Exclusion criteria: 1) women with pre-existing diabetes mellitus 2)women with pcos on metformin therapy 3)women who are having bleeding or pain abdomen 4) women who are known case of chronic medical disorder such as hypertension,chronic liver disease ,cardiovascular diseases 5) active infections like TB,HIV,Malaria,other febrile illness 6) Multiple pregnancy

Design outcomes

Primary

Measure	Time frame
Compare proportion of women with early gestational intolerance who develop gestational intolerance or gestational diabetes in medical nutrition therapy versus metformin and medical nutrition therapyTimepoint: 8 to 9 weeks,11 to 12 weeks,14 to 16 weeks,24 to 28 weeks,32 to 34 weeks	—

Secondary

Measure	Time frame
Foetal & maternal complications Foetal outcome includes LGA,FGR,preterm,subcutaneous thickness,ponderal index,proportion of newborn with admission in nursery or NICU,still birth,early neonatal deaths Maternal outcomes include hypertension,cesarean delivery,polyhydromnios,shoulder dystocia,weight gain during pregnancyTimepoint: 37 to 40 weeks of gestation age	—

Countries

India

Contacts

Public ContactDr Srilekha Thupili

Lady hardinge medical college

pikeesaxena@gmail.com9868223323

Outcome results