Insulin in Treatment of Diabetes Mellitus With Pregnancy

Assiut University

Status: Completed

Conditions: Diabetes

Treatments: Drug: Basal insulin analogue; Drug: rapid acting insulin; Drug: regular insulin; Drug: Neutral Protamine Hagedorn

Study type: Interventional

Funder types: Other

Identifiers

NCT04726631

IS-PREG

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Basal insulin analogue and premeal rapid acting insulin

Other group

Treatment:

Drug: rapid acting insulin

Drug: Basal insulin analogue

Neutral Protamine Hagedorn with regular insulin

Other group

Treatment:

Drug: regular insulin

Drug: Neutral Protamine Hagedorn