Diabetes in Pregnancy and Pregnancy Outcomes

Study Overview
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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.

Official Title
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Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

Conditions
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Diabetes Mellitus in Pregnancy, Diabetes, Gestational

Intervention / Treatment
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* Dietary Supplement: Medical Nutrition Therapy
* Drug: Insulin
* Drug: Oral Antidiabetics


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Good Outcome<br>Good outcome is defined as the safe delivery of the newborn. | Dietary Supplement: Medical Nutrition Therapy<br>* Only given medical nutrition therapy.<br>Drug: Insulin<br>* Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.<br>Drug: Oral Antidiabetics<br>* Prescribed with all types of oral anti-diabetics.<br>|
| Poor Outcome<br>Poor outcome is defined as the incidence of fetal demise during pregnancy. | Dietary Supplement: Medical Nutrition Therapy<br>* Only given medical nutrition therapy.<br>Drug: Insulin<br>* Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.<br>Drug: Oral Antidiabetics<br>* Prescribed with all types of oral anti-diabetics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Mortality | Maternal death as recorded in medical records | Throughout the length of pregnancy, an average of 9 months | 
| 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 | 
| Method of Delivery | Vaginal Birth or Caesarean Section as recorded in medical records | At time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus in pregnancy, gestational diabetes, pregnancy outcomes