Gestational DiabetesOTSASNCT03073330
One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening
A study testing GDM screening with 75 g 2 hour GTT and GDM screening with two step approach in people with Gestational Diabetes, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- GDM screening with 75 g 2 hour GTT and GDM screening with two step approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-50 year of age
- Pregnant women (limits the participants to female gender)
Who cannot join
- Pregestational Diabetes Mellitus
- History of bariatric surgery
Trial locations and contacts
1 site in 1 country.
Adeeb Khalifeh, MD contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Adeeb Khalifeh, MD, adeeb.khalifeh@jefferson.edu
About this study
Official title: One vs Two Step Approach for GDM Screening
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- GDM screening with 75 g 2 hour GTT, GDM screening with two step approach
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| One Step | Experimental | The intervention is gestational diabetes screening with 2 hour GTT 75 g load. Receives: 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. Receives: Diagnostic Test: GDM screening with two step approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the time of the screening
Secondary outcomes (10)
neonatal hyperbilirubinemia
incidence of neonatal hyperbilirubinemia
Measured: first 48 hours of life
mode of delivery
incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor
Measured: at time of delivery
gestational age at delivery
gestational age at delivery
Measured: at time of delivery
Anal sphincter injury
Incidence of Anal sphincter injury
Measured: at time of delivery
Shoulder dystocia
incidence of shoulder dystocia, and birth trauma
Measured: at time of delivery
Neonatal complications
includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal intensive care unit
Measured: between birth and 28 days of age
Hypertensive disorders in pregnancy
includes gestational hypertension, preeclampsia
Measured: 6 months
Fetal growth restriction, large for gestational age and polyhydramnios
Incidence of Fetal growth restriction,large for gestational age and polyhydramnios
Measured: 6 months
Birth weight
Mean of birth weight and incidence of macrosomia
Measured: Time of delivery
Apgar score
Apgar score
Measured: at 1, 5 and 10 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJun 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, adeeb khalifeh, Thomas Jefferson University
- Investigators
- Adeeb Khalifeh, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073330
- Sponsor's protocol ID
- 8550
- Acronym
- OTSAS
- Status last verified
- Mar 2017
- First submitted
- 11 Aug 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12081977
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One vs Two Step Approach for GDM Screening
- ClinicalTrials.gov ID
- NCT03073330
- Acronym / sponsor ID
- OTSAS / 8550
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Step | Experimental | Diagnostic Test: GDM screening with 75 g 2 hour GTTThe intervention is gestational diabetes screening with 2 hour GTT 75 g load. |
| Two Step | Active comparator | Diagnostic Test: GDM screening with two step approachThere is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 16-50 year of age
- Pregnant women (limits the participants to female gender)
Key exclusion criteria (2 listed)
- Pregestational Diabetes Mellitus
- History of bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDM screening with 75 g 2 hour GTTPatients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl. | Diagnostic test | One Step |
| GDM screening with two step approach1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive | Diagnostic test | Two Step |
Primary outcome
Incidence of gestational diabetes diagnosed on each screening test of each arm.
Time frame: 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
10 secondary outcomes
neonatal hyperbilirubinemia
Time frame: first 48 hours of life
mode of delivery
Time frame: at time of delivery
gestational age at delivery
Time frame: at time of delivery
Anal sphincter injury
Time frame: at time of delivery
Shoulder dystocia
Time frame: at time of delivery
Neonatal complications
Time frame: between birth and 28 days of age
Hypertensive disorders in pregnancy
Time frame: 6 months
Fetal growth restriction, large for gestational age and polyhydramnios
Time frame: 6 months
Birth weight
Time frame: Time of delivery
Apgar score
Time frame: at 1, 5 and 10 minutes after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Results publication: PubMed 12081977Southwick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeeb Khalifeh, MD contact
Adeeb Khalifeh principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDM screening with 75 g 2 hour GTT and GDM screening with two step approach in people with Gestational Diabetes, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeeb Khalifeh, MD (adeeb.khalifeh@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gestational diabetes diagnosed on each screening test of each arm. (time frame: at the time of the screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.