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Diabetes in Pregnancy and Pregnancy Outcomes

NCT03602846 — Completed, 45 participants, Tarumanagara University
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Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

RegistryNCT03602846
StatusCompleted
Study typeObservational
Enrollment45 (Actual)
SponsorTarumanagara University (Other); collaborators: Hermina Podomoro Hospital
ConditionsDiabetes Mellitus in Pregnancy, Diabetes, Gestational
InterventionsMedical Nutrition Therapy, Insulin, Oral Antidiabetics (Dietary supplement, drug)
Datesstart 2015-01-01, primary completion 2015-12-01, completion 2016-06-01, first posted 2018-07-27, last updated 2018-07-27

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-Summary

To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Good OutcomeDietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral AntidiabeticsGood outcome is defined as the safe delivery of the newborn.
Poor OutcomeDietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral AntidiabeticsPoor outcome is defined as the incidence of fetal demise during pregnancy.
  • Medical Nutrition Therapy (Dietary supplement): Only given medical nutrition therapy.
  • Insulin (Drug): Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
  • Oral Antidiabetics (Drug): Prescribed with all types of oral anti-diabetics.

+Outcome measures

Primary outcomes

  • 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
  • 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
  • Infant Head Circumference [At time of delivery]: Infant Head Circumference as recorded in medical records
  • APGAR Score [At time of delivery]: One and five minute APGAR Scores as recorded in medical records

Secondary outcomes

  • 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

Other outcomes

  • Random Plasma Glucose [Throughout the length of pregnancy, an average of 9 months]: Random Plasma Glucose levels as recorded in medical records
  • Fasting Plasma Glucose [Throughout the length of pregnancy, an average of 9 months]: Fasting Plasma Glucose levels as recorded in medical records
  • Oral Glucose Tolerance Test [Throughout the length of pregnancy, an average of 9 months]: Oral Glucose Tolerance Test levels as recorded in medical records
  • Glycated Hemoglobin (HbA1c) [Throughout the length of pregnancy, an average of 9 months]: Glycated Hemoglobin (HbA1c) levels as recorded in medical records

+Eligibility

Sex: Female, accepts healthy volunteers

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

+Investigators

My Notes