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Clinical Trials/PACTR201804003328818
PACTR201804003328818
Not yet recruiting
未知

A community-based randomised trial of lifestyle intervention using targeted shared care approach on pregnancy outcomes in Nigerian women with gestational diabetes mellitus but without diabetes mellitus

International Diabetes Federation0 sites514 target enrollmentApril 14, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Pregnancy and Childbirth
Sponsor
International Diabetes Federation
Enrollment
514
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 14, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
International Diabetes Federation

Eligibility Criteria

Inclusion Criteria

  • Pregnant women 18 years and above;
  • Pregnant women between 24th\-28th who fulfill the diagnostic criteria of GDM:
  • Diagnosis of GDM will be by one\-step standard 75\-gram 2\-hour oral glucose tolerance test using the International Association of Diabetes and Pregnancy Study Group¿s criteria.
  • Fasting Blood Sugar \- equal or more than 5\.2mmol/l to \<7\.0mmol/l
  • 2\-hours Post Prandial \- equal or more than 8\.0 mmol/l to \<11\.1mmol/l

Exclusion Criteria

  • Pregnant women younger than 18 years;
  • Pregnant women who fulfill diagnostic criteria for diabetes mellitus (fasting PG equal or more than 7\.0 mmol/L, 2\-hour PG equal or more than 11\.1 mmol/L or HbA1c equal or more than 6\.5% );
  • pre\-existing/pregestational DM;
  • multiple pregnancy;
  • blood type incompatibility between mother and foetus, ABO type (pre\-emptively exclude Rhesus negative mothers;
  • and maternal diseases: such as chronic hypertension, thyrotoxicosis, or use of long\-term medicines that could alter glucose metabolism.

Outcomes

Primary Outcomes

Not specified

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