Insulin in Treatment of Diabetes Mellitus With Pregnancy

NCT04726631 | Completed

• 1 other identifier: IS-PREG
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• the percentage of maternal glycosylated Hemoglobin

  6 months

Study Arms (2)

Basal insulin analogue and premeal rapid acting insulin

OTHER

Drug: Basal insulin analogue; Drug: rapid acting insulin

Neutral Protamine Hagedorn with regular insulin

OTHER

Drug: Neutral Protamine Hagedorn; Drug: regular insulin

Interventions

Basal insulin analogue DRUG

Analogue insulin is a sub-group of human insulin

Basal insulin analogue and premeal rapid acting insulin

rapid acting insulin DRUG

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.

Basal insulin analogue and premeal rapid acting insulin

Neutral Protamine Hagedorn DRUG

is an intermediate-acting insulin

Neutral Protamine Hagedorn with regular insulin

regular insulin DRUG

is a type of short-acting insulin.

Neutral Protamine Hagedorn with regular insulin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin, Short-Acting; Insulin, Isophane; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Proinsulin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: January 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01