Insulin in Treatment of Diabetes Mellitus With Pregnancy

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726631
• Other study ID #: IS-PREG
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Basal insulin analogue
Analogue insulin is a sub-group of human insulin
• rapid acting 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.
• Neutral Protamine Hagedorn
is an intermediate-acting insulin
• regular insulin
is a type of short-acting insulin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of maternal glycosylated Hemoglobin		6 months