Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)

niversity of Oxford0 sites1,870 target enrollmentDecember 21, 2018

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33597136/ protocol (added 22/02/2021)

Registry

who.int

Start Date

December 21, 2018

End Date

September 16, 2022

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

•Current inclusion criteria as of 07/05/2020:
•1\. Aged 18 years or older
•2\. Gestational age \= 16 weeks
•3\. Meeting at least one of the following criteria for high\-risk gestational diabetes mellitus (GDM):
•3\.1\. Booking BMI \= 25kg/m²
•3\.2\. Age \= 25 years
•3\.3\. First\-degree relative with diabetes
•3\.4\. Previous pregnancy with GDM
•3\.5\. Previous pregnancy with large baby (\= 3\.5kg)
•3\.6\. Previous pregnancy with pre\-eclampsia/eclampsia

•Current inclusion criteria as of 07/05/2020:
•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 gestations in the current pregnancy
•4\. History of severe hyperemesis in the first trimester
•5\. Uncontrolled pre\-gestational or gestational hypertension (BP \> 150/100 mmHg) on treatment
•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