Diabetes in Pregnancy and Pregnancy Outcomes

NCT03602846 | Completed

• 1 other identifier: APS002
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus in Pregnancy; Diabetes, Gestational

Keywords

diabetes mellitus in pregnancy; gestational diabetes; pregnancy outcomes

Outcome Measures

Primary Outcomes (6)

• Infant Mortality

  Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records

  Throughout the length of pregnancy, an average of 9 months

• Gestational Age at Birth

  Infant Gestational at Birth as recorded in medical records

  At time of delivery

• Infant Body Weight

  Infant Body Weight as recorded in medical records

  At time of delivery

• Infant Body Length

  Infant Body Length as recorded in medical records

  At time of delivery

• Infant Head Circumference

  Infant Head Circumference as recorded in medical records

  At time of delivery

• APGAR Score

  One and five minute APGAR Scores as recorded in medical records

  At time of delivery

Secondary Outcomes (3)

• 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

Other Outcomes (4)

• Random Plasma Glucose

  Throughout the length of pregnancy, an average of 9 months

• Fasting Plasma Glucose

  Throughout the length of pregnancy, an average of 9 months

• Oral Glucose Tolerance Test

  Throughout the length of pregnancy, an average of 9 months

Study Arms (2)

Good Outcome

Good outcome is defined as the safe delivery of the newborn.

Dietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral Antidiabetics

Poor Outcome

Poor outcome is defined as the incidence of fetal demise during pregnancy.

Dietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral Antidiabetics

Interventions

Medical Nutrition Therapy DIETARY_SUPPLEMENT

Only given medical nutrition therapy.

Good Outcome; Poor Outcome

Insulin DRUG

Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.

Good Outcome; Poor Outcome

Oral Antidiabetics DRUG

Prescribed with all types of oral anti-diabetics.

Good Outcome; Poor Outcome

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy is still undergoing
• Incomplete record of glycemic profile, management and fetal outcomes

Sponsors & Collaborators

• Tarumanagara University: lead
• Hermina Podomoro Hospital: collaborator

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Nutrition Therapy; Insulin; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anthony P Sunjaya

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 27, 2018
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 27, 2018

Record last verified: 2018-07