Insulin in Treatment of Diabetes Mellitus With Pregnancy

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: Neutral Protamine Hagedorn; Drug: Basal insulin analogue; Drug: regular insulin; Drug: rapid acting insulin

• Registration Number: NCT04726631
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Last Update Submitted: 2021-01-23
• Study First Posted: 2021-01-27
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral Protamine Hagedorn with regular insulin	regular insulin	-
Basal insulin analogue and premeal rapid acting insulin	rapid acting insulin	-
Neutral Protamine Hagedorn with regular insulin	Neutral Protamine Hagedorn	-
Basal insulin analogue and premeal rapid acting insulin	Basal insulin analogue	-

Primary Outcome Measures

Name	Time	Method
the percentage of maternal glycosylated Hemoglobin	6 months