The Healthy Start for My Baby Study

Overview

Status: Recruiting
Keywords: Women's Health , Gestational Diabetes
IRB Number: 00063969
Specialty: Maternal-Fetal Medicine
Sub Specialties:

Brief Summary

We hypothesize that a structured Diabetes Management Program for Pregnancy (DMP-P) will remove the obstacle of meal planning and preparation, making compliance with a diabetic diet much more convenient. We postulate that this will improve glycemic control, resulting in fewer patients requiring medication to control their diabetes, a decreased amount of medication for those who do need medication, less need for intervention, and fewer complications. Specifically, our primary outcome will be to compare cesarean delivery rates between the DMP-P and standard care groups, with secondary outcomes assessing differences in the rates of macrosomia (birthweight over 4000g), large for gestational age (weight >90th percentile for gestational age), need for medication (oral hypoglycemics and/or insulin), and mean glucose and hemoglobin A1C level differences.
 

Detailed Description

We hypothesize that a structured Gestational Diabetes Management Program (GDM-P) will remove the obstacle of meal planning and preparation, making compliance with a diabetic diet much more convenient. We postulate that this will improve glycemic control, resulting in fewer patients requiring medication to control their diabetes, less need for intervention, and fewer complications. Specifically, our primary outcome will be to compare cesarean delivery rates between the two groups, with secondary outcomes assessing differences in the rates of macrosomia (birthweight over 4000g), large for gestational age (weight >90th percentile for gestational age), need for medication (oral hypoglycemics and/or insulin), and mean glucose and hemoglobin A1C level differences.

Principal Investigator: Michael Draper
Department: Maternal-Fetal Medicine
Co Investigator:

Contact Information

Name:Jacob Draper
Phone: 801 213 2240
Email: jacob.draper@hsc.utah.edu

Inclusion Criteria

Women age 18 years or older at enrollment.

Women who are pregnant with a diagnosis of pregestational diabetes

OR

Women diagnosed with gestational diabetes at any time in their current pregnancy by any one of the following standard criteria:

- fasting plasma glucose value >=126 mg/dL

- hemoglobin A1C >=6.5%

- any plasma glucose value >=190mg/dL, including a standard screening glucola.

- two elevated values on a 3 hour glucose tolerance test. (American Diabetes Association cutoffs in mg/dL: fasting plasma glucose >=95, 1 hour plasma glucose >=180, 2 hour >=155, and 3 hour >=140) (11)

 

Exclusion Criteria

-Known or suspected allergies to any component of the prepackaged meals 

-Any contraindication to oral hypoglycemics and insulin.

-Any diagnosed absorption syndrome.

-Any diagnosed eating disorder

-Multiple gestation (twins, triplets, or more)

-Distance precludes patient picking up meals or delivery of meals (generally this will be about 30 miles from the meal distribution site)

-Inadequate English to give informed consent

-Greater than 33 weeks at randomization