Insulin in Treatment of Diabetes Mellitus With Pregnancy

Study Overview
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Brief Summary
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The prevalence of diabetes melilites is rapidly increasing over years and consequently during pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of which 86.4% of them were diagnosed with gestational diabetes melilites. Pregnancy in women with diabetes is associated with an intensification in adverse maternal, fetal and perinatal outcomes including spontaneous abortions, congenital malformations, preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through all pregnancy markedly improves both maternal and fetal outcomes. Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary control and exercise fail. However, insulin therapy has its difficulties like approaches to mimicking postprandial insulin release, providing adequate background insulin, balancing insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a struggle for doctors and patients and much affecting their lifestyle

Official Title
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Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Basal insulin analogue
* Drug: rapid acting insulin
* Drug: Neutral Protamine Hagedorn
* Drug: regular insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 - 45 years old, Women with pre-gestational diabetes. Those who were under premixed insulin therapy prior to pregnancy. women pregnant between 14 weeks up to 28 weeks of gestation Exclusion Criteria: History of recurrent miscarriage multiple pregnancies chronic hypertension severe heart, liver, and kidney disease. women how got pregnant after assisted reproduction those with advanced retinopathy, hypersensitivity to insulin. Women who developed bleeding in early pregnancy and those diagnosed to have any major anomaly during the first-trimester scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Basal insulin analogue and premeal rapid acting insulin<br> | Drug: Basal insulin analogue<br>* Analogue insulin is a sub-group of human insulin<br>Drug: rapid acting insulin<br>* Rapid acting insulins are usually taken just before or with a meal. They act very quickly to minimise the rise in blood sugar which follows eating.<br>|
| Other: Neutral Protamine Hagedorn with regular insulin<br> | Drug: Neutral Protamine Hagedorn<br>* is an intermediate-acting insulin<br>Drug: regular insulin<br>* is a type of short-acting insulin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of maternal glycosylated Hemoglobin |  | 6 months |