Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)

Pregnancy Clinical Trial

— GDM2  

Official title:

Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309138
• Other study ID #: PRO14070556
• Secondary ID: R01HD079647
• Status: Completed
• Phase: N/A
• Start date: August 11, 2015
• Est. completion date: June 5, 2020

Study information

• Verified date: July 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.

Description:

Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indication of long-term metabolic dysfunction leading to diabetes and cardiovascular disease. In the US, GDM is diagnosed using a two-step screening and diagnostic approach. The International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed a one-step diagnostic approach that broadens the definition of GDM by lowering the cutoff values to include women with milder forms of hyperglycemia, who would have screened normal under the current two-step approach. The goal of these recommendations is better identification of women at risk for pregnancy complications and long-term metabolic dysfunction, but it results in a significant increase in the prevalence of GDM. The NIH GDM Consensus Development Conference committee does not recommend changing from the current two-step screening/diagnostic approach to the IADPSG one-step diagnostic approach without trials demonstrating that increasing the number of women diagnosed as having GDM results in better outcomes. We aim to 1) conduct a "real world" randomized controlled trial (RCT) to determine differences in short-term perinatal health outcomes between the two predominant GDM screening approaches, and 2) prospectively follow the mothers to examine their metabolic risk profiles and the growth of their infants at 1 year postpartum. Based on a pilot study, we propose a single site blinded RCT of 920 pregnant women ages 18-45 years without a diagnosis of diabetes, with a singleton pregnancy (18-24 wks gestation). Participants will have a non-fasting 1 hour 50 gm glucose challenge test (GCT) performed between 24-28 weeks' gestation. Women with 50 gm GCT results < 200 mg/dL will be randomized to receive either a fasting 2 hour 75 gm oral glucose tolerance test (OGTT) or a 3 hour 100 gm OGTT. GDM will be diagnosed using the IADPSG criteria for women receiving the 75 gm OGTT and Carpenter-Coustan criteria for women receiving the 100 gm. Participants and their physicians will be informed of the diagnosis of GDM, but blinded to the specific test results and diagnostic criteria. Participants with GDM will receive treatment from their primary provider. Questionnaires will be used to assess participants' and physicians' views on GDM testing. Metabolic profiles will be assessed at randomization and at a year postpartum. The primary outcome measure is large-for-gestational age fetal growth. The rationale for this RCT is that this is a unique opportunity to compare the two methods. At the end of the study, we will know whether women diagnosed at lower glucose levels with the IADPSG criteria are more likely to have adverse perinatal outcomes. We hypothesize that using IADPSG diagnostic criteria will result in greater detection of women with impaired glucose metabolism and treating these women will reduce adverse perinatal outcomes and prevent long-term metabolic dysfunction. This study will provide level A data for endorsing universal screening guidelines for GDM by major organizations and implementation into clinical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 921
• Est. completion date: June 5, 2020
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnancy between 18-24 weeks of gestation

• Singleton gestation

• Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania

Exclusion Criteria:

• Preexisting type 1 or 2 diabetes

• Diabetes diagnosed at less than 24 weeks gestational age (GA)

• Multiple gestations ( e.g. twins or triplets)

• Hypertension requiring medications

• Corticosteroid (IM, oral or IV) use in the 30 days prior to enrollment

• Major congenital anomaly with anticipated preterm delivery due to maternal or fetal indications < 28 wks GA

• Inability to complete the glucose testing before 30 completed weeks GA

• Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucola solution.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Pregnancy

Intervention

Diagnostic Test:
• Gestational diabetes screening with fasting 3 hour 100 gm
Participants receive fasting 3 hour 100 gm oral glucose tolerance test
• Gestational diabetes screening with fasting 2 hour 75g
Participants receive fasting 2 hour 75 gm oral glucose tolerance test

Locations

Country	Name	City	State
United States	UPMC- Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Esa M Davis, MD MPH FAAFP	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Abebe KZ, Scifres C, Simhan HN, Day N, Catalano P, Bodnar LM, Costacou T, Matthew D, Illes A, Orris S, Duell J, Ly K, Davis EM. Comparison of Two Screening Strategies for Gestational Diabetes (GDM(2)) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large for Gestational Age (LGA) Infant	birth weight equal to or greater than the 90th percentile for gestational age and sex	at time of delivery
Secondary	Cesarean Delivery	the delivery of a baby through a surgical incision in the mother's abdomen and uterus	at delivery (approximately 40 weeks' gestation)
Secondary	Maternal Composite Morbidity	maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage	at delivery (approximately 40 weeks' gestation)
Secondary	Neonatal Composite Morbidity	1) hypoglycemia: blood glucose < 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries.	7 days after birth