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Completed

NCT Number: NCT03602846

Diabetes in Pregnancy and Pregnancy Outcomes

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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Key information

Conditions

Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Gestational Age at Birth

    Time frame: At time of delivery

    Infant Gestational at Birth as recorded in medical records

  3. Infant Body Weight

    Time frame: At time of delivery

    Infant Body Weight as recorded in medical records

  4. Infant Body Length

    Time frame: At time of delivery

    Infant Body Length as recorded in medical records

  5. Infant Head Circumference

    Time frame: At time of delivery

    Infant Head Circumference as recorded in medical records

  6. APGAR Score

    Time frame: At time of delivery

    One and five minute APGAR Scores as recorded in medical records

Secondary outcomes

  1. Maternal Mortality

    Time frame: Throughout the length of pregnancy, an average of 9 months

    Maternal death as recorded in medical records

  2. Comorbidities

    Time frame: 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

  3. Method of Delivery

    Time frame: At time of delivery

    Vaginal Birth or Caesarean Section as recorded in medical records

Other outcomes

  1. Random Plasma Glucose

    Time frame: Throughout the length of pregnancy, an average of 9 months

    Random Plasma Glucose levels as recorded in medical records

  2. Fasting Plasma Glucose

    Time frame: Throughout the length of pregnancy, an average of 9 months

    Fasting Plasma Glucose levels as recorded in medical records

  3. Oral Glucose Tolerance Test

    Time frame: Throughout the length of pregnancy, an average of 9 months

    Oral Glucose Tolerance Test levels as recorded in medical records

  4. Glycated Hemoglobin (HbA1c)

    Time frame: Throughout the length of pregnancy, an average of 9 months

    Glycated Hemoglobin (HbA1c) levels as recorded in medical records

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Hermina Podomoro Hospital

Registry information

Official study title

Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 27, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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