sebbacon
commented
6 years ago Investigation notes:
- Downloaded raw JSON for dates straddling that entry (
raw_clincialtrials_json_2018-05-21.csvandraw_clincialtrials_json_2018-05-23.csv) from our Cloud Storage archive - The record is present in both and identical in both (except for the sentence ClinicalTrials.gov processed this data on May 18, 2018, which was May 18 and May 22)
{
"clinical_study": {
"required_header": {
"download_date": "ClinicalTrials.gov processed this data on May 18, 2018",
"link_text": "Link to the current ClinicalTrials.gov record.",
"url": "https://clinicaltrials.gov/show/NCT03073330"
},
"id_info": {
"org_study_id": "8550",
"nct_id": "NCT03073330"
},
"brief_title": "One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening",
"acronym": "OTSAS",
"official_title": "One vs Two Step Approach for GDM Screening",
"sponsors": {
"lead_sponsor": {
"agency": "Thomas Jefferson University",
"agency_class": "Other"
}
},
"source": "Thomas Jefferson University",
"oversight_info": {
"has_dmc": "No"
},
"brief_summary": {
"textblock": "Our study will assess if there is a difference in incidence of gestational diabetes using\n different screening approaches, either using a one-step approach with a 2 hour glucose\
n tolerance test or using a two-step approach. Prior studies have proven similar incidences\n including a randomized controlled trial."
},
"detailed_description": {
"textblock": "Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain\n amount of glucose and testing blood glucose level one hour after drinking it. If th
is value\n is above a certain cut-off (>135mg/dl), the patient is subjected to another test involving\n drinking a solution containing a higher amount of glucose and checking blood glucose while
\n fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two\n step approach).\n\n Cut off values will be: 3 hour>180 mg/dl, 2 hour > 155 mg/dl, 1hour >140 m
g/dl, fasting\n >95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes.\n\n In other parts of the United States, and most of the rest of the word, screening for\n ges
tational diabetes uses a one-step approach by drinking a solution containing 75g of\n glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the\n International
Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values\n are checked at fasting, one hour and two hours after solution drinking.\n\n The diagnosis of gestational diabetes
is based on one elevated values. (cut off: Fasting\n ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl).\n\n Our study will assess if there is a difference in incidence of gestational diabetes usin
g\n these different screening approaches. Prior studies have proven similar incidences including\n a randomized controlled trial."
},
"overall_status": "Recruiting",
"start_date": "June 2016",
"completion_date": {
"type": "Anticipated",
"text": "June 2017"
},
"primary_completion_date": {
"type": "Anticipated",
"text": "March 2017"
},
"phase": "N/A",
"study_type": "Interventional",
"has_expanded_access": "No",
"study_design_info": {
"allocation": "Randomized",
"intervention_model": "Parallel Assignment",
"primary_purpose": "Diagnostic",
"masking": "None (Open Label)"
},
"primary_outcome": {
"measure": "Incidence of gestational diabetes diagnosed on each screening test of each arm.",
"time_frame": "at the time of the screening",
"description": "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"
},
"secondary_outcome": [
{
"measure": "neonatal hyperbilirubinemia",
"time_frame": "first 48 hours of life",
"description": "incidence of neonatal hyperbilirubinemia"
},
{
"measure": "mode of delivery",
"time_frame": "at time of delivery",
"description": "incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor"
},
{
"measure": "gestational age at delivery",
"time_frame": "at time of delivery",
"description": "gestational age at delivery"
},
{
"measure": "Anal sphincter injury",
"time_frame": "at time of delivery",
"description": "Incidence of Anal sphincter injury"
},
{
"measure": "Shoulder dystocia",
"time_frame": "at time of delivery",
"description": "incidence of shoulder dystocia, and birth trauma"
},
{
"measure": "Neonatal complications",
"time_frame": "between birth and 28 days of age",
"description": "includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal i
ntensive care unit"
},
{
"measure": "Hypertensive disorders in pregnancy",
"time_frame": "6 months",
"description": "includes gestational hypertension, preeclampsia"
},
{
"measure": "Fetal growth restriction, large for gestational age and polyhydramnios",
"time_frame": "6 months",
"description": "Incidence of Fetal growth restriction,large for gestational age and polyhydramnios"
},
{
"measure": "Birth weight",
"time_frame": "Time of delivery",
"description": "Mean of birth weight and incidence of macrosomia"
},
{
"measure": "Apgar score",
"time_frame": "at 1, 5 and 10 minutes after birth",
"description": "Apgar score"
}
],
"number_of_arms": "2",
"enrollment": {
"type": "Anticipated",
"text": "284"
},
"condition": "Gestational Diabetes",
"arm_group": [
{
"arm_group_label": "One Step",
"arm_group_type": "Experimental",
"description": "The intervention is gestational diabetes screening with 2 hour GTT 75 g load."
},
{
"arm_group_label": "Two Step",
"arm_group_type": "Active Comparator",
"description": "There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load."
}
],
"intervention": [
{
"intervention_type": "Diagnostic Test",
"intervention_name": "GDM screening with 75 g 2 hour GTT",
"description": "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.",
"arm_group_label": "One Step"
},
{
"intervention_type": "Diagnostic Test",
"intervention_name": "GDM screening with two step approach",
"description": "1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive",
"arm_group_label": "Two Step"
}
],
"eligibility": {
"criteria": {
"textblock": "Inclusion Criteria:\n\n - 16-50 year of age\n\n - Pregnant women (limits the participants to female gender)\n\n Exclusion Criteria:\n\n - Pregest
ational Diabetes Mellitus\n\n - History of bariatric surgery"
},
"gender": "Female",
"gender_based": "Yes",
"gender_description": "Pregnant women (limits the participants to female gender)",
"minimum_age": "16 Years",
"maximum_age": "50 Years",
"healthy_volunteers": "Accepts Healthy Volunteers"
},
"overall_official": {
"last_name": "Adeeb Khalifeh",
"role": "Principal Investigator",
"affiliation": "Thomas Jefferson University"
},
"overall_contact": {
"last_name": "Adeeb Khalifeh, MD",
"email": "adeeb.khalifeh@jefferson.edu"
},
"location": {
"facility": {
"name": "Thomas Jefferson University Hospital",
"address": {
"city": "Philadelphia",
"state": "Pennsylvania",
"zip": "19107",
"country": "United States"
}
},
"status": "Recruiting",
"contact": {
"last_name": "Adeeb Khalifeh, MD",
"email": "adeeb.khalifeh@jefferson.edu"
}
},
"location_countries": {
"country": "United States"
},
"results_reference": {
"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.",
"PMID": "12081977"
},
"verification_date": "March 2017",
"study_first_submitted": "August 11, 2016",
"study_first_submitted_qc": "March 2, 2017",
"study_first_posted": {
"type": "Actual",
"text": "March 8, 2017"
},
"last_update_submitted": "March 2, 2017",
"last_update_submitted_qc": "March 2, 2017",
"last_update_posted": {
"type": "Actual",
"text": "March 8, 2017"
},
"responsible_party": {
"responsible_party_type": "Principal Investigator",
"investigator_affiliation": "Thomas Jefferson University",
"investigator_full_name": "adeeb khalifeh",
"investigator_title": "Physician Fellow"
},
"condition_browse": {
"mesh_term": "Diabetes, Gestational"
},
"patient_data": {
"sharing_ipd": "No"
}
}
}
NickCEBM
To catalogue an issue from the other day, this trial:
https://clinicaltrials.gov/ct2/show/NCT03073330
Appeared in the May 23rd update of the data, however it looks like it should have appeared much earlier and it hasn't changed anything recently. Couldn't figure out why it only just appeared on the tracker.