Diabetes in Pregnancy and Pregnancy Outcomes

Completed

• Conditions: Diabetes Mellitus in Pregnancy; Diabetes, Gestational
• Interventions: Dietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral Antidiabetics

• Registration Number: NCT03602846
• Lead Sponsor: Tarumanagara University

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Study First Submitted: 2018-06-27
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-18
• Last Update Submitted: 2018-07-18
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Good Outcome	Oral Antidiabetics	Good outcome is defined as the safe delivery of the newborn.
Poor Outcome	Medical Nutrition Therapy	Poor outcome is defined as the incidence of fetal demise during pregnancy.
Poor Outcome	Oral Antidiabetics	Poor outcome is defined as the incidence of fetal demise during pregnancy.
Good Outcome	Medical Nutrition Therapy	Good outcome is defined as the safe delivery of the newborn.
Poor Outcome	Insulin	Poor outcome is defined as the incidence of fetal demise during pregnancy.
Good Outcome	Insulin	Good outcome is defined as the safe delivery of the newborn.

Primary Outcome Measures

Name	Time	Method
APGAR Score	At time of delivery	One and five minute APGAR Scores as recorded in medical records
Infant Mortality	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	At time of delivery	Infant Head Circumference as recorded in medical records
Gestational Age at Birth	At time of delivery	Infant Gestational at Birth as recorded in medical records
Infant Body Weight	At time of delivery	Infant Body Weight as recorded in medical records
Infant Body Length	At time of delivery	Infant Body Length as recorded in medical records

Secondary Outcome Measures

Name	Time	Method
Maternal Mortality	Throughout the length of pregnancy, an average of 9 months	Maternal death as recorded in medical records
Comorbidities	Throughout the length of pregnancy, an average of 9 months	Comorbid conditions were defined as either concomitant hypertension, anemia, urinary tract infection, preeclampsia/eclampsia, or combinations of them as recorded in medical records
Method of Delivery	At time of delivery	Vaginal Birth or Caesarean Section as recorded in medical records