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Clinical Trials/TCTR20220119002
TCTR20220119002
Unknown
Phase 3

THE EFFECT OF BREASTFEEDING AND DIETARY INTERVENTION ON BREASTFEEDING PRACTICES AND POSTPARTUM GLUCOSE PROFILE IN WOMEN WITH GESTATIONAL DIABETES MELLITUS

IVERSITI TEKNOLOGI MARA0 sites64 target enrollmentJanuary 19, 2022

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus
Sponsor
IVERSITI TEKNOLOGI MARA
Enrollment
64
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2022
End Date
February 28, 2023
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
IVERSITI TEKNOLOGI MARA

Eligibility Criteria

Inclusion Criteria

  • Pregnant women aged 18\-45 years with 20 weeks of gestation or later
  • Primiparous women with singleton pregnancy
  • Pre\-pregnancy BMI \>22\.9 kg/m2
  • Women who were diagnosed with GDM with more than 1 75g oral glucose tolerance test (OGTT) values exceeding established thresholds (fasting 5\.1 mmol/l, 1 hour 10\.0 mmol/l, 2 hours 8\.5 mmol/l).
  • On a diet\-controlled alone
  • Women who receive antenatal care at selected Health Clinic; Meru Health Clinic, Sungai Buloh Health Clinic, and Kuala Selangor Health Clinic
  • Have the intention to breastfeed
  • Have telephone access
  • Malaysian women

Exclusion Criteria

  • Women whose illness or medication prevented her from breastfeeding the infants
  • Infant admitted to the Neonatal Intensive Care Unit (NICU)
  • Women who have already diagnosed with T1DM or T2DM
  • Women who were diagnosed with overt diabetes (at least presence with one of the following; FBG more or equal to 7\.0 mmol/L or random plasma glucose (RPG) more or equal to 11\.1mmol/L)
  • Women who have a severe infection such as HIV, human T\- cell lymphotropic virus type I or II infection, or active tuberculosis
  • Carrying fetus with confirmed congenital anomalies which is unable to receive breastmilk naturally
  • Women who are unable to communicate in English or Malay.
  • Multiple pregnancies

Outcomes

Primary Outcomes

Not specified

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