Randomization of Early Diabetes Screening Among Obese Pregnant Women.

NCT03116009 | Terminated Phase 3 FDA Drug

• 1 other identifier: 2016-0737
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomization of two groups of obese pregnant women into early screening for diabetes mellitus at the time of their first or subsequent prenatal visits before 20 weeks of gestation versus standard time of screening for diabetes at 24 - 28 weeks as it is done for all pregnant women. The perinatal outcomes between the two groups will be compared to determine whether early screening for diabetes in all obese pregnant women has a clinical merit or significant.

Conditions

Gestational Diabetes

Keywords

Obesity; Pregnancy; Diabetes Mellitus; Perinatal Outcomes

Outcome Measures

Primary Outcomes (1)

• Large for gestational age or macrosomia

  Birth weight of newborn more than 90 percentile or birth weight of 4000gm or more will be assessed at the completion of that pregnancy.

  To be assessed within 2 days after delivery.

Secondary Outcomes (4)

• Maternal medical complications

  For 6 months during antepartum and 6 weeks postpartum.

• Birth injuries

  To be assessed within 2 days of delivery.

• Mode of delivery

  To be assessed within 2 days of delivery.

• Glycemic control

  To be assessed during pregnancy and 6 weeks postpartum.

Study Arms (2)

Screening for diabetes with 1-hour GCT and HbA1

ACTIVE COMPARATOR

Participants in this group will do 1-hour GCT before 20 weeks of gestation. Those with positive test will undergo 3-hours OGTT. Diabetes will be diagnosed if they have two or more abnormal values out of the 4 values and they will be treated accordingly based on the institutional protocol. They will also have HbA1C done.

Drug: Screening for diabetes with 1-hour GCT and HbA1

Early screening with only HbA1C

EXPERIMENTAL

Participants in this group will only have HbA1C done before 20 weeks but will do the standard diabetes screening at 24 - 28 weeks. Those who have abnormal values will also be treated based on the institutional protocol.

Drug: Screening for diabetes with 1-hour GCT and HbA1

Interventions

Screening for diabetes with 1-hour GCT and HbA1 DRUG

They will receive 50gm oral glucose tolerance test before 20 weeks and if abnormal, they will do the diagnostic test with 100gm OGTT with HbA1C.

Also known as: Early screening with only HbA1C

Early screening with only HbA1C; Screening for diabetes with 1-hour GCT and HbA1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Only obese pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese pregnant women with BMI \> 30 kg/m2
• First prenatal visit or subsequent visit prior to 20 weeks of gestation
• Maternal age \> 18 years
• Willingness to participate in the study and give informed consent

You may not qualify if:

• Pre-existing DM or pre-gestational diabetes mellitus,
• Gestational age more than 20 weeks at time of enrollment
• Unknown or inability to determine gestational age even with last menstrual period
• Previous medical history of gestational diabetes mellitus.
• Known impaired glucose metabolism
• HbA1C \> 6.5 %

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Obesity; Diabetes Mellitus

Interventions

Mass Screening; glutaminyl-peptide cyclotransferase; Glycated Hemoglobin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Glycated Serum Proteins; Glycated Proteins; Glycation End Products, Advanced; Glycoconjugates; Carbohydrates; Glycoproteins; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Toxins, Biological; Biological Factors

Study Officials

• Mary D Stephenson, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: Two groups of obese pregnant women: Group 1: They will be screened for diabetes mellitus before 20 weeks of gestation. Group 2: They will be screened for diabetes mellitus at 24 - 28 weeks.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: April 14, 2017
• Study Start: March 19, 2017
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)