Diabetes in Pregnancy and Pregnancy Outcomes

NCT ID: NCT03602846

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus in Pregnancy Diabetes, Gestational

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Good Outcome

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

Medical Nutrition Therapy

Intervention Type DIETARY_SUPPLEMENT

Only given medical nutrition therapy.

Insulin

Intervention Type DRUG

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

Oral Antidiabetics

Intervention Type DRUG

Prescribed with all types of oral anti-diabetics.

Poor Outcome

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

Medical Nutrition Therapy

Intervention Type DIETARY_SUPPLEMENT

Only given medical nutrition therapy.

Insulin

Intervention Type DRUG

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

Oral Antidiabetics

Intervention Type DRUG

Prescribed with all types of oral anti-diabetics.

Interventions

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Medical Nutrition Therapy

Only given medical nutrition therapy.

Intervention Type DIETARY_SUPPLEMENT

Insulin

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

Intervention Type DRUG

Oral Antidiabetics

Prescribed with all types of oral anti-diabetics.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hermina Podomoro Hospital

UNKNOWN

Sponsor Role collaborator

Tarumanagara University

OTHER

Sponsor Role lead

Responsible Party

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Anthony Paulo Sunjaya

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony P Sunjaya

Role: PRINCIPAL_INVESTIGATOR

Tarumanagara University

Other Identifiers

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APS002

Identifier Type: -

Identifier Source: org_study_id

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