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Clinical Trials/ACTRN12615000904572
ACTRN12615000904572
Completed
未知

For pregnant women with a first trimester HbA1c in the pre-diabetes range, does intensive management including blood sugar monitoring to maintain normoglycaemia, compared to standard weight gain and dietary advice, improve pregnancy outcome. A feasibility trial for PINTO.

Ruth Hughes0 sites150 target enrollmentAugust 31, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Ruth Hughes
Enrollment
150
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 31, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Ruth Hughes

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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