Prevention of Gestational Diabetes by multi-pronged intervention - A cluster RCT

Effectiveness of multipronged intervention strategy in reducing the incidence of gestational diabetes mellitus among the high-risk pregnant mothers attending primary health care centers of Puducherry â?? A cluster randomized controlled trial.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043989

Enrollment

1200

Registered

2022-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Health Condition 1: O098- Supervision of other high risk pregnancies

Interventions

Intervention1: Multi-pronged intervention: This intervention will be given for a maximum of 8 months, i.e. from the registration of the pregnancy till delivery Control Intervention1: Standard Care Gro

Eligibility

Inclusion criteria

Inclusion criteria: Early registration (within 1st trimester) before 12 weeks of gestation Euglycemic and not a known case of diabetes with one of the following high-risk conditions for GDM 1.Age more than >25yrs 2.Pre-pregnancy Body mass index (BMI) >23 kg/m2 3.History of GDM, miscarriage, large for gestational age (LGA) ( >4kgs), congenital anomalies 4.Women with symptoms suggestive of PCOS. 5.Family history of Diabetes Mellitus or Gestational diabetes mellitus

Exclusion criteria

Exclusion criteria: 1.Women undergoing steroid therapy 2.Women whose BMI is 3.History of pre-term birth, repeated miscarriage 4.Women with chronic heart disease, rheumatic arthritits, severe anemia, Hyperemissive and renal disease. 5.Induced/assisted conception

Design outcomes

Primary

Measure	Time frame
Incidence of GDMTimepoint: 24-28 weeks of gestation and 37 weeks of gestation	—

Secondary

Measure	Time frame
Birth OutcomesTimepoint: After 37 weeks of gestation	—

Countries

India

Contacts

Public ContactDr Venkatachalam J

JIPMER

drvenkatpgi@gmail.com9244489850

Outcome results

None listed

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