Insulin in Treatment of Diabetes Mellitus With Pregnancy

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT04726631

Collaborator

(none)

110

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Basal insulin analogue Drug: rapid acting insulin Drug: Neutral Protamine Hagedorn Drug: regular insulin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Basal insulin analogue and premeal rapid acting insulin	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.
Other: Neutral Protamine Hagedorn with regular insulin	Drug: Neutral Protamine Hagedorn is an intermediate-acting insulin Drug: regular insulin is a type of short-acting insulin.

Arm

Intervention/Treatment

Other: Basal insulin analogue and premeal rapid acting insulin

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.

Other: Neutral Protamine Hagedorn with regular insulin

Drug: Neutral Protamine Hagedorn

is an intermediate-acting insulin

Drug: regular insulin

is a type of short-acting insulin.

Outcome Measures

Primary Outcome Measures

the percentage of maternal glycosylated Hemoglobin [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Khairy Ali, Assistant professor, Assiut University

ClinicalTrials.gov Identifier:

NCT04726631

Other Study ID Numbers:

IS-PREG

First Posted:

Jan 27, 2021

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Insulin

Insulin, Globin Zinc

Insulin, Short-Acting

Protamines

Study Results

No Results Posted as of Jan 27, 2021