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Clinical Trials/TCTR20220802008
TCTR20220802008
Unknown
Phase 1

THE EFFECT OF BREASTFEEDING AND DIETARY INTERVENTION ON BREASTFEEDING PRACTICES AND POSTPARTUM GLUCOSE PROFILE IN WOMEN WITH GESTATIONAL DIABETES MELLITUS: A RANDOMISED CONTROLLED TRIA

MARA University of Technology0 sites64 target enrollmentAugust 2, 2022
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ConditionsGestational diabetes mellitusdiabetes in pregnancy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gestational diabetes mellitus
Sponsor
MARA University of Technology
Enrollment
64
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 2, 2022
End Date
June 30, 2023
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Pregnant women aged 18 to 45 years with 20 weeks of gestation or later
  • •2\. Primiparous women with a singleton pregnancy
  • •3\. Pre\-pregnancy BMI more than 22\.9 kg m2
  • •4\. Women who were diagnosed with GDM with more than or equal to 1 75g oral glucose tolerance test (OGTT) values exceeding established thresholds (fasting 5\. 5\.1 mmoll, 1 hour 10\.0 mmoll, 2 hours 8\.5 mmoll).
  • •5\. On a diet\-controlled alone
  • •6\. Women who receive antenatal care at Meru Health Clinic, Sungai 7\. Buloh Health Clinic, and Kuala Selangor Health Clinic
  • •8\. Have the intention to breastfeed
  • •9\. Have telephone access
  • •10\. Malaysian women

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
Phase 3
THE EFFECT OF BREASTFEEDING AND DIETARY INTERVENTION ON BREASTFEEDING PRACTICES AND POSTPARTUM GLUCOSE PROFILE IN WOMEN WITH GESTATIONAL DIABETES MELLITUSGestational Diabetes MellitusBreastfeedingDietary ManagementGlucose controlT2DM
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