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A Clinical trial to study the need for starting antiglycaemic agents by 2 point vs 4 point blood glucose profile monitoring every 2 weeks in Gestational Diabetes Mellitus patients controlled on Diet and Excercise between 28-36 weeks of Gestation

Comparison of need for antiglycaemic agents between 2-point and 4- point blood glucose profile monitoring every 2 weeks in women with Gestational Diabetes Mellitus controlled with diet between 28-36weeks of gestation -A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082248
Enrollment
318
Registered
2025-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: 2 point profile every two weeks in GDM A1 Women: GDM A1 Women will be advised to check their blood glucose 2 times in a day Fasting ,2 hours Post breakfast, every 2 weeks. Control Int

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: More than 18 years age, Singleton viable pregnancy , Diagnosed as GDM with 75gm OGTT using IADPSG criteria 2010, Controlled with diet as evidenced by a normal 4-point profile (Fasting less than 95 and 2 hours blood glucose post meal-breakfast, lunch and dinner less than 120mg/dl) in the preceding 2 weeks , Enrolment 24-28 weeks of gestation , Study period 28- 36 weeks of gestation

Exclusion criteria

Exclusion criteria: Known case of Type1/2DM

Design outcomes

Primary

MeasureTime frame
Need for antiglycaemic agentsTimepoint: Need for antiglycaemic agents from 28 weeks till 36 weeks of gestation—

Secondary

MeasureTime frame
Maternal- GHTN/PE Adherence to the testing Recurrent urinary tract infections/vulvovaginal candidiasis. Diabetic ketoacidosis. Polyhydramnios/Oligohydramnios. Premature rupture of membranes (PROM)/Preterm prelabour rupture of membranes (PPROM). Antepartum haemorrhage. Operative delivery (Assisted vaginal delivery/ caesarean sec-tion), Postpartum haemorrhage, Gestational weight gain Timepoint: from 28 weeks of gestation till delivery;Perinatal- Macrosomia/ LGA Low birth weight (LBW)./Small for gestational age. Shoulder dystocia. Bone fracture. Nerve palsy. Respiratory distress syndrome. Neonatal hypoglycaemia-requiring intravenous treatment/ jaundice/hypocalcaemia. Neonatal intensive care unit admission. Intrauterine growth restriction. Congenital anomaly. Preterm Birth. Hypoxic Ischaemic Encephalopathy. Mortality- (stillbirth/ foetal & Neonatal death). Timepoint: perinatal period—

Countries

India

Contacts

Public ContactDr Haritha Sagili

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

harithasagili@gmail.com9489390630

Outcome results

None listed

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