Insulin in Treatment of Diabetes Mellitus With Pregnancy

NCT ID: NCT04726631

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2019-12-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basal insulin analogue and premeal rapid acting insulin

Group Type: OTHER

Basal insulin analogue

Intervention Type: DRUG

Analogue insulin is a sub-group of human insulin

rapid acting insulin

Intervention Type: 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.

Neutral Protamine Hagedorn with regular insulin

Group Type: OTHER

Neutral Protamine Hagedorn

Intervention Type: DRUG

is an intermediate-acting insulin

regular insulin

Intervention Type: DRUG

is a type of short-acting insulin.

Interventions

Basal insulin analogue

Analogue insulin is a sub-group of human insulin

Intervention Type: DRUG

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.

Intervention Type: DRUG

Neutral Protamine Hagedorn

is an intermediate-acting insulin

Intervention Type: DRUG

regular insulin

is a type of short-acting insulin.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IS-PREG

Identifier Type: -

Identifier Source: org_study_id