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Insulin in Treatment of Diabetes Mellitus With Pregnancy

NCT04726631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-01-27

No results posted yet for this study

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

Interventions

DRUG

Basal insulin analogue

Analogue insulin is a sub-group of human insulin

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.

DRUG

Neutral Protamine Hagedorn

is an intermediate-acting insulin

DRUG

regular insulin

is a type of short-acting insulin.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2019-09-01
Completion
2019-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726631 on ClinicalTrials.gov