CTRI/2018/07/014947
Recruiting
Phase 3
Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)
Department of Biotechnology Newton Fund Global Research Programme0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitus
- Sponsor
- Department of Biotechnology Newton Fund Global Research Programme
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible pregnant women should be
- •(1\) aged 18 years or older
- •(2\) Gestational age 16 weeks or lesser
- •(3\) Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre\-eclampsia)
- •(4\) Meet at least one of the following criteria that qualifies them as â??high\-riskâ??: for GDM
- •Booking BMI \>\=25kg/m2,
- •Age \>\=25 years,
- •First\-degree relative with diabetes,
- •Previous pregnancy with GDM and/or pre\- eclampsia/eclampsia,
- •Previous pregnancy with large baby (\>\=3\.5kg),
Exclusion Criteria
- •Women will be excluded if they meet one or more of the following criteria
- •(1\) GDM diagnosed prior to screening visit based on IADPSG criteria or documented raised HbA1C, i.e., either fasting glucose \>\=5\.1 mmol/L or 1h glucose \>\=10\.0 mmol/L or 2h glucose \>\=8\.5 mmol/L, or a documented HbA1c of \>\=6\.5% at first booking
- •(2\) History of pre\-gestational diabetes
- •(3\) Multiple gestation in the current pregnancy
- •(4\) History of severe hyperemesis in the first trimester
- •(5\) Uncontrolled pre\-gestational or gestational hypertension (BP \>150/100 mmHg) or currently on treatment hypertension
- •(6\) History of recurrent (\>\=2\) first trimester spontaneous abortions or stillbirths
- •(7\) Previous child born with congenital anomalies
- •(8\) History of significant ante\- or post\-partum haemorrhage in the previous pregnancy.
- •(9\) Pregnancy following in\-vitro fertilization or any assisted reproductive technology
Outcomes
Primary Outcomes
Not specified
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