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临床试验/NCT03073330
NCT03073330Unknown不适用

One vs Two Step Approach for GDM Screening

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
284
试验地点
1
主要终点
Incidence of gestational diabetes diagnosed on each screening test of each arm.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •Pregestational Diabetes Mellitus
  • •History of bariatric surgery

研究组 & 干预措施

One Step

Experimental

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

干预措施: GDM screening with 75 g 2 hour GTT (Diagnostic Test)

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.

干预措施: GDM screening with two step approach (Diagnostic Test)

结局指标

主要结局

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

时间窗: at the time of the screening

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

次要结局

  • neonatal hyperbilirubinemia(first 48 hours of life)
  • Birth weight(Time of delivery)
  • mode of delivery(at time of delivery)
  • Neonatal complications(between birth and 28 days of age)
  • Fetal growth restriction, large for gestational age and polyhydramnios(6 months)
  • Anal sphincter injury(at time of delivery)
  • Hypertensive disorders in pregnancy(6 months)
  • gestational age at delivery(at time of delivery)
  • Shoulder dystocia(at time of delivery)
  • Apgar score(at 1, 5 and 10 minutes after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

adeeb khalifeh

Physician Fellow

Thomas Jefferson University

研究点 (1)

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