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Randomization of Early Diabetes Screening Among Obese Pregnant Women. (REDSOAP)

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ClinicalTrials.gov Identifier: NCT03116009
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Enakpene, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment
Gestational Diabetes Diagnostic Test: Screening for diabetes mellitus before 20 weeks of gestation and then undergo diagnostic test

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomization of Early Versus Standard Diabetes Screening Among Obese Pregnant Women
Actual Study Start Date : March 19, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Early diabetes screening
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.
Diagnostic Test: Screening for diabetes mellitus before 20 weeks of gestation and then undergo diagnostic test
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.
Other Name: Standard screening for diabetes mellitus between 24 - 28 weeks and then undergo diagnostic test.
Experimental: Standard diabetes screening
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.
Diagnostic Test: Screening for diabetes mellitus before 20 weeks of gestation and then undergo diagnostic test
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.
Other Name: Standard screening for diabetes mellitus between 24 - 28 weeks and then undergo diagnostic test.



Primary Outcome Measures :
  1. Large for gestational age or macrosomia [ Time Frame: To be assessed within 2 days after delivery. ]
    Birth weight of newborn more than 90 percentile or birth weight of 4000gm or more will be assessed at the completion of that pregnancy.


Secondary Outcome Measures :
  1. Maternal medical complications [ Time Frame: For 6 months during antepartum and 6 weeks postpartum. ]
    Development of preeclampsia

  2. Birth injuries [ Time Frame: To be assessed within 2 days of delivery. ]
    Third or 4th degree perineal lacerations will be assessed soon after successful vaginal delivery either spontaneous or with assisted vaginal delivery.

  3. Mode of delivery [ Time Frame: To be assessed within 2 days of delivery. ]
    Normal vaginal delivery, operative vaginal delivery or cesarean section

  4. Glycemic control [ Time Frame: To be assessed during pregnancy and 6 weeks postpartum. ]
    Use of HbA1C, and postpartum glucose challenge test as postpartum visit.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only obese pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116009


Contacts
Contact: Christopher A Enakpene, MD, FACOG 347 217 5127 cenakpene@gmail.com
Contact: Dimitrios Mastrogiannis, MD, Ph.D, FACOG 312 996 7300 dmastro@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Christopher A Enakpene, MD    347-217-5127    cenakpen@uic.edu   
Contact: Micaela Della Torre, MD MS    312 543 8813    micaela@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago

Responsible Party: Christopher Enakpene, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03116009     History of Changes
Other Study ID Numbers: 2016-0737
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Enakpene, University of Illinois at Chicago:
Obesity
Pregnancy
Diabetes Mellitus
Perinatal Outcomes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications