NCT03073330

Brief Summary

Our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. Prior studies have proven similar incidences including a randomized controlled trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

August 11, 2016

Last Update Submit

March 2, 2017

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Incidence of gestational diabetes diagnosed on each screening test of each arm.

    Gestational diabetes will be made based on one abnormal value. Fasting ≥126 mg/dl; 1 hour≥ 180 mg/dl and 2 hour ≥ 153 mg/dl

    at the time of the screening

Secondary Outcomes (10)

  • neonatal hyperbilirubinemia

    first 48 hours of life

  • mode of delivery

    at time of delivery

  • gestational age at delivery

    at time of delivery

  • Anal sphincter injury

    at time of delivery

  • Shoulder dystocia

    at time of delivery

  • +5 more secondary outcomes

Study Arms (2)

One Step

EXPERIMENTAL

The intervention is gestational diabetes screening with 2 hour GTT 75 g load.

Diagnostic Test: GDM screening with 75 g 2 hour GTT

Two Step

ACTIVE COMPARATOR

There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load.

Diagnostic Test: GDM screening with two step approach

Interventions

GDM screening with 75 g 2 hour GTTDIAGNOSTIC_TEST

Patients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl.

One Step
GDM screening with two step approachDIAGNOSTIC_TEST

1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive

Two Step

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women (limits the participants to female gender)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year of age
  • Pregnant women (limits the participants to female gender)

You may not qualify if:

  • Pregestational Diabetes Mellitus
  • History of bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Southwick AM, Wang LX, Long SR, Lee YC. Activity of Sinorhizobium meliloti NodAB and NodH enzymes on thiochitooligosaccharides. J Bacteriol. 2002 Jul;184(14):4039-43. doi: 10.1128/JB.184.14.4039-4043.2002.

    PMID: 12081977RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Adeeb Khalifeh

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeeb Khalifeh, MD

CONTACT

adeeb.khalifeh@jefferson.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Fellow

Study Record Dates

First Submitted

August 11, 2016

First Posted

March 8, 2017

Study Start

June 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)