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Diabetes in Pregnancy and Pregnancy Outcomes

Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03602846
Enrollment
45
Registered
2018-07-27
Start date
2015-01-31
Completion date
2016-06-30
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Diabetes Mellitus in Pregnancy

Keywords

diabetes mellitus in pregnancy, gestational diabetes, pregnancy outcomes

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.

Interventions

DIETARY_SUPPLEMENTMedical Nutrition Therapy

Only given medical nutrition therapy.

DRUGInsulin

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

DRUGOral Antidiabetics

Prescribed with all types of oral anti-diabetics.

Sponsors

Hermina Podomoro Hospital
CollaboratorUNKNOWN
Tarumanagara University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Body WeightAt time of deliveryInfant Body Weight as recorded in medical records
Infant MortalityThroughout the length of pregnancy, an average of 9 monthsInfant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Gestational Age at BirthAt time of deliveryInfant Gestational at Birth as recorded in medical records
Infant Body LengthAt time of deliveryInfant Body Length as recorded in medical records
APGAR ScoreAt time of deliveryOne and five minute APGAR Scores as recorded in medical records
Infant Head CircumferenceAt time of deliveryInfant Head Circumference as recorded in medical records

Secondary

MeasureTime frameDescription
Method of DeliveryAt time of deliveryVaginal Birth or Caesarean Section as recorded in medical records
Maternal MortalityThroughout the length of pregnancy, an average of 9 monthsMaternal death as recorded in medical records
ComorbiditiesThroughout the length of pregnancy, an average of 9 monthsComorbid conditions were defined as either concomitant hypertension, anemia, urinary tract infection, preeclampsia/eclampsia, or combinations of them as recorded in medical records

Other

MeasureTime frameDescription
Random Plasma GlucoseThroughout the length of pregnancy, an average of 9 monthsRandom Plasma Glucose levels as recorded in medical records
Glycated Hemoglobin (HbA1c)Throughout the length of pregnancy, an average of 9 monthsGlycated Hemoglobin (HbA1c) levels as recorded in medical records
Oral Glucose Tolerance TestThroughout the length of pregnancy, an average of 9 monthsOral Glucose Tolerance Test levels as recorded in medical records
Fasting Plasma GlucoseThroughout the length of pregnancy, an average of 9 monthsFasting Plasma Glucose levels as recorded in medical records

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026