NCT02309138

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
921

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

August 11, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

November 25, 2014

Results QC Date

July 2, 2020

Last Update Submit

July 2, 2020

Conditions

Gestational DiabetesPregnancyGlucose Intolerance

Keywords

gestational diabetes screeningCarpenter Coustan CriteriaIADPSG criteriaLarge for gestational age birth weight

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cesarean Delivery

    at delivery (approximately 40 weeks' gestation)

  • Maternal Composite Morbidity

    at delivery (approximately 40 weeks' gestation)

  • Neonatal Composite Morbidity

    7 days after birth

Study Arms (2)

3 hour 100 gm OGTT (CC Criteria)

ACTIVE COMPARATOR

Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.

Diagnostic Test: Gestational diabetes screening with fasting 3 hour 100 gm

2 hr 75 gm OGTT (IADPSG Criteria)

ACTIVE COMPARATOR

Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.

Diagnostic Test: Gestational diabetes screening with fasting 2 hour 75g

Interventions

Gestational diabetes screening with fasting 3 hour 100 gmDIAGNOSTIC_TEST

Participants receive fasting 3 hour 100 gm oral glucose tolerance test

3 hour 100 gm OGTT (CC Criteria)
Gestational diabetes screening with fasting 2 hour 75gDIAGNOSTIC_TEST

Participants receive fasting 2 hour 75 gm oral glucose tolerance test

2 hr 75 gm OGTT (IADPSG Criteria)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnancy between 18-24 weeks of gestation
  • Singleton gestation
  • Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC- Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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 (GDM2) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18.

    PMID: 28823926BACKGROUND

  • Scifres CM, Davis EM, Orris S, Costacou T, Lalama C, Abebe KZ, Catalano P. Metabolic factors and perinatal outcomes among pregnant individuals with mild glucose intolerance. Diabetes Res Clin Pract. 2024 Oct;216:111830. doi: 10.1016/j.diabres.2024.111830. Epub 2024 Aug 17.

    PMID: 39159865DERIVED

  • Davis EM, Abebe KZ, Simhan HN, Catalano P, Costacou T, Comer D, Orris S, Ly K, Decker A, Mendez D, Day N, Scifres CM. Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jul 1;138(1):6-15. doi: 10.1097/AOG.0000000000004431.

    PMID: 34259458DERIVED

MeSH Terms

Conditions

Diabetes, GestationalGlucose Intolerance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Results Point of Contact

Title
Director of Center for Research on Health Care Data Center
Organization
University of Pittsburgh
dcenter@pitt.edu
412-692-2023

Study Officials

  • Esa M Davis, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 5, 2014

Study Start

August 11, 2015

Primary Completion

July 3, 2019

Study Completion

June 5, 2020

Last Updated

July 20, 2020

Results First Posted

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Once the study is completed and the investigators have published the main manuscripts regarding the outcomes of the trial. De-identified data will be made available by request, review and approval of the investigators and the institution regulatory committee.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared in the appropriate time frame required by policy.
Access Criteria
An application and review process will be implemented for accessing data.

Locations

US(1)