louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02377531: Early Screen and Treatment for Gestational Diabetes
Official title: Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: early glucose screen, perinatal outcome
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 1020
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the current study we aim to determine if early glucose screening and treatment among women at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and treatment if necessary and the other half to a standard 24-28 weeks glucose screen.


Eligibility criteria: Inclusion Criteria:

Pregnant subjects 18-45 y/o and Any of the following:

Obesity defined as having a BMI\>30 kg/m2 History of pregnancy complicated with GDM History of pregnancy complicated with macrosomia First degree relative with diabetes Multiple gestation

Exclusion Criteria:

* Incomplete Data: if any data is missing (i.e Delivery data) , analysis cannot be completed.

Pregnancy complicated with fetal malformations or aneuploidy: It affects prenatal care, mode of delivery as well as perinatal outcome.

Pregestational or Overt Diabetes: Patients with Diabetes cannot be diagnosed with GDM.

Chronic medical conditions such as hypertension, renal disease, autoimmune conditions: Those conditions may affect prenatal care, perinatal morbidity.

Early diabetes screen performed prior to enrollment in study: Participant cannot be randomized, and probably have been treated.

Medical contraindication to glucose tolerance test (bariatric surgery): patients with h/o gastric bypass frequently cannot tolerate oral glucose load, therefore cannot be screened for GDM in the traditional way.

Primary outcomes:
measure: Composite Perinatal morbidity
timeFrame: up to 28 days after birth
Secondary outcomes:
measure: Maternal weight gain
timeFrame: up to delivery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Tampa
country: United States
facility: TGH Health Park Genesis Clinic
state: Florida
Study officials:
affiliation: University of South Florida
name: Alejandro Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Judette Louis, MD, MPH
role: STUDY_CHAIR
affiliation: University of South Florida
name: Linda Odibo
role: STUDY_DIRECTOR
References: