Clinical trial NCT03073330: One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening
Official title: One vs Two Step Approach for GDM Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 284
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. If this value is above a certain cut-off (\>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two step approach).

Cut off values will be: 3 hour\>180 mg/dl, 2 hour \> 155 mg/dl, 1hour \>140 mg/dl, fasting \>95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes.

In other parts of the United States, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the International Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values are checked at fasting, one hour and two hours after solution drinking.

The diagnosis of gestational diabetes is based on one elevated values. (cut off: Fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl).

Our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. Prior studies have proven similar incidences including a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* 16-50 year of age
* Pregnant women (limits the participants to female gender)

Exclusion Criteria:

* Pregestational Diabetes Mellitus
* History of bariatric surgery

Primary outcomes:
measure: Incidence of gestational diabetes diagnosed on each screening test of each arm.
timeFrame: at the time of the screening
Secondary outcomes:
measure: neonatal hyperbilirubinemia
timeFrame: first 48 hours of life
measure: mode of delivery
timeFrame: at time of delivery
measure: gestational age at delivery
timeFrame: at time of delivery
measure: Anal sphincter injury
timeFrame: at time of delivery
measure: Shoulder dystocia
timeFrame: at time of delivery
measure: Neonatal complications
timeFrame: between birth and 28 days of age
measure: Hypertensive disorders in pregnancy
timeFrame: 6 months
measure: Fetal growth restriction, large for gestational age and polyhydramnios
timeFrame: 6 months
measure: Birth weight
timeFrame: Time of delivery
measure: Apgar score
timeFrame: at 1, 5 and 10 minutes after birth
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adeeb Khalifeh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.