Feasibility trial for PINTO: pre-diabetes in pregnancy, can early intensive management and lifestyle advice improve outcomes?

Not Applicable

Completed

• Conditions: Prediabetes in pregnancy; Reproductive Health and Childbirth - Antenatal care; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12615000904572
• Lead Sponsor: Ruth Hughes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Women with an HbA1c level of 41-46mmol/mol and who are <14 weeks’ gestation with an ongoing pregnancy.

Exclusion Criteria

Women with HbA1c levels greater than or equal to 47mmol/mol. Women with known diabetes. Women carrying a fetus with a known lethal congenital anomaly and / or an abnormal karyotype / chromosomal abnormality. Women planning to terminate the pregnancy. Women taking metformin to manage pre-diabetes or polycystic ovarian syndrome will be excluded from the study and referred to the local antenatal diabetes clinic, or be advised to have an early 75g oral glucose tolerance test (OGTT) depending on local policy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified