Clinical trial NCT03602846: Diabetes in Pregnancy and Pregnancy Outcomes
Official title: Diabetes in Pregnancy, Therapy and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus in Pregnancy
Diabetes, Gestational
Keywords: diabetes mellitus in pregnancy
gestational diabetes
pregnancy outcomes
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Hermina Podomoro Hospital
First posted: 2018-07-27
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Mortality
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Gestational Age at Birth
timeFrame: At time of delivery
measure: Infant Body Weight
timeFrame: At time of delivery
measure: Infant Body Length
timeFrame: At time of delivery
measure: Infant Head Circumference
timeFrame: At time of delivery
measure: APGAR Score
timeFrame: At time of delivery
Secondary outcomes:
measure: Maternal Mortality
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Comorbidities
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Method of Delivery
timeFrame: At time of delivery
Other outcomes:
measure: Random Plasma Glucose
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Fasting Plasma Glucose
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Oral Glucose Tolerance Test
timeFrame: Throughout the length of pregnancy, an average of 9 months
measure: Glycated Hemoglobin (HbA1c)
timeFrame: Throughout the length of pregnancy, an average of 9 months
Locations:
Study officials:
affiliation: Tarumanagara University
name: Anthony P Sunjaya
role: PRINCIPAL_INVESTIGATOR
References: