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Completed

NCT Number: NCT04726631

Insulin in Treatment of Diabetes Mellitus With Pregnancy

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basal insulin analogue

Drug

Analogue insulin is a sub-group of human insulin

rapid acting insulin

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

Drug

is an intermediate-acting insulin

Regular insulin

Drug

is a type of short-acting insulin.

Primary outcomes

  1. the percentage of maternal glycosylated Hemoglobin

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2021
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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