Diabetes in Pregnancy, Therapy and Pregnancy Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Medical Nutrition Therapy
- Conditions
- Diabetes Mellitus in Pregnancy
- Sponsor
- Tarumanagara University
- Enrollment
- 45
- Primary Endpoint
- APGAR Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.
Detailed Description
Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus. This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.
Investigators
Anthony Paulo Sunjaya
Principle Investigator
Tarumanagara University
Eligibility Criteria
Inclusion Criteria
- •Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
- •Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester
Exclusion Criteria
- •Pregnancy is still undergoing
- •Incomplete record of glycemic profile, management and fetal outcomes
Arms & Interventions
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
Intervention: Medical Nutrition Therapy
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
Intervention: Insulin
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
Intervention: Oral Antidiabetics
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
Intervention: Medical Nutrition Therapy
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
Intervention: Insulin
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
Intervention: Oral Antidiabetics
Outcomes
Primary Outcomes
APGAR Score
Time Frame: At time of delivery
One and five minute APGAR Scores as recorded in medical records
Infant Mortality
Time Frame: Throughout the length of pregnancy, an average of 9 months
Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Infant Head Circumference
Time Frame: At time of delivery
Infant Head Circumference as recorded in medical records
Gestational Age at Birth
Time Frame: At time of delivery
Infant Gestational at Birth as recorded in medical records
Infant Body Weight
Time Frame: At time of delivery
Infant Body Weight as recorded in medical records
Infant Body Length
Time Frame: At time of delivery
Infant Body Length as recorded in medical records
Secondary Outcomes
- Maternal Mortality(Throughout the length of pregnancy, an average of 9 months)
- Comorbidities(Throughout the length of pregnancy, an average of 9 months)
- Method of Delivery(At time of delivery)