Diabetes in Pregnancy and Pregnancy Outcomes

Diabetes, Gestational Clinical Trial

Official title:

Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602846
• Other study ID #: APS002
• Status: Completed
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2018
• Source: Faculty of Medicine, Tarumanagara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus in Pregnancy
• Diabetes, Gestational
• Pregnancy in Diabetics

Intervention

Dietary Supplement:
• Medical Nutrition Therapy
Only given medical nutrition therapy.

Drug:
• Insulin
Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
• Oral Antidiabetics
Prescribed with all types of oral anti-diabetics.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, Tarumanagara University	Hermina Podomoro Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Random Plasma Glucose	Random Plasma Glucose levels as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Other	Fasting Plasma Glucose	Fasting Plasma Glucose levels as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Other	Oral Glucose Tolerance Test	Oral Glucose Tolerance Test levels as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Other	Glycated Hemoglobin (HbA1c)	Glycated Hemoglobin (HbA1c) levels as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Primary	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
Primary	Gestational Age at Birth	Infant Gestational at Birth as recorded in medical records	At time of delivery
Primary	Infant Body Weight	Infant Body Weight as recorded in medical records	At time of delivery
Primary	Infant Body Length	Infant Body Length as recorded in medical records	At time of delivery
Primary	Infant Head Circumference	Infant Head Circumference as recorded in medical records	At time of delivery
Primary	APGAR Score	One and five minute APGAR Scores as recorded in medical records	At time of delivery
Secondary	Maternal Mortality	Maternal death as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Secondary	Comorbidities	Comorbid conditions were defined as either concomitant hypertension, anemia, urinary tract infection, preeclampsia/eclampsia, or combinations of them as recorded in medical records	Throughout the length of pregnancy, an average of 9 months
Secondary	Method of Delivery	Vaginal Birth or Caesarean Section as recorded in medical records	At time of delivery