- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726631
Insulin in Treatment of Diabetes Mellitus With Pregnancy
Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Basal insulin analogue and premeal rapid acting insulin
|
Analogue insulin is a sub-group of human insulin
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.
|
Other: Neutral Protamine Hagedorn with regular insulin
|
is an intermediate-acting insulin
is a type of short-acting insulin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the percentage of maternal glycosylated Hemoglobin
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IS-PREG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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