Gestational DiabetesGD2MNCT01540396
Gestational Diabetes Diagnostic Methods
A study testing Dietary modification and medications in people with Gestational Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Dietary modification and medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2014
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Plan to undergo gestational diabetes screening at 24-28 weeks' gestation.
Who cannot join
- Existing Type 1 or Type 2 diabetes
- Diabetes diagnosed early in pregnancy (less than 24 weeks gestation)
- Multiple gestation (e.g. twins, triplets)
- Chronic hypertension (requiring medications)
- Oral, IM or IV corticosteroid use within the previous 30 days
- Major congenital anomaly or anticipated preterm delivery before 28 weeks
- Inability to complete 50 gram GCT before 28 completed weeks' gestation
- Patients with known HIV, Hepatitis B or C virus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: GD2M Study:Gestational Diabetes Diagnostic Methods
This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. The two methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1 hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and Coustan criteria).
Read the detailed description
This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation to test the investigators recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes.
Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the ob/gyn outpatient practices at Magee-Women's hospital (MWH). Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test. Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test (OGTT)or the 3 hour 100 gm OGGT within two weeks. Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria. Patients and their providers will be informed of the diagnosis of gestational diabetes, but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing.
Chart reviews will be conducted to assess for perinatal maternal and infant health factors (e.g.pregnancy weight, gestational weight gain, co morbidities) as well as for data on perinatal outcomes related to GDM such as macrosomia, c-sections, and birth trauma. Two brief self-administered questionnaire will assess participants' views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures.
At the end of this pilot study, the investigators will have experience with recruitment, retention, and randomization procedures and have made the necessary protocol revisions. If successful, this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes.
- Conditions
- Gestational Diabetes
- Being tested
- Dietary modification and medications
- Keywords
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modification and medicationsBehavioural
Patients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control.
| Study group | Role | What they receive |
|---|---|---|
| 75 Gram OGTT | Active comparator | The 2011 ADA criteria will be used to diagnose gestational diabetes in this study arm. Receives: Behavioral: Dietary modification and medications |
| 100 gram OGTT | Active comparator | A 2 step approach to the diagnosis of gestational diabetes will be used in this arm. Patients who have a 50 gram, 1 hour glucose challenge test result greater than 135 mg/dL will be diagnosed with gestational diabetes if their 3 hour, 100 gram OGTT results exceed the diagnostic threshold recommended by Carpenter and Coustan. Receives: Behavioral: Dietary modification and medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrosomia
Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams
Measured: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Cesarean delivery
Primary or repeat cesarean delivery
Measured: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Diagnosis of gestational diabetes
Assess how frequently a diagnosis of gestational diabetes is made
Measured: Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)
Secondary outcomes (5)
Pre-eclampsia or gestational hypertension
New onset hypertension +/- proteinuria
Measured: Will be assessed from study enrollment until 30 days after delivery
Neonatal hypoglycemia
Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery
Measured: First 24 hours of life
Neonatal hyperbilirubinemia
Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick
Measured: First 7 days of life
Infant birth trauma
Defined as shoulder dystocia/brachial plexus injuries
Measured: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Maternal birth trauma
3rd or 4th degree perineal laceration or postpartum hemorrhage
Measured: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M Scifres, MD, Principal investigator, University of PittsburghEsa Davis, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540396
- Sponsor's protocol ID
- PRO11080682
- Acronym
- GD2M
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2012
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GD2M Study:Gestational Diabetes Diagnostic Methods
- ClinicalTrials.gov ID
- NCT01540396
- Acronym / sponsor ID
- GD2M / PRO11080682
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Feb 2012 (estimated)
- 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.
This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. The two methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1 hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and Coustan criteria).
Detailed description
This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation to test the investigators recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes.
Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the ob/gyn outpatient practices at Magee-Women's hospital (MWH). Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test. Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test (OGTT)or the 3 hour 100 gm OGGT within two weeks. Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria. Patients and their providers will be informed of the diagnosis of gestational diabetes, but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing.
Chart reviews will be conducted to assess for perinatal maternal and infant health factors (e.g.pregnancy weight, gestational weight gain, co morbidities) as well as for data on perinatal outcomes related to GDM such as macrosomia, c-sections, and birth trauma. Two brief self-administered questionnaire will assess participants' views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures.
At the end of this pilot study, the investigators will have experience with recruitment, retention, and randomization procedures and have made the necessary protocol revisions. If successful, this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 75 Gram OGTT | Active comparator | Behavioral: Dietary modification and medicationsThe 2011 ADA criteria will be used to diagnose gestational diabetes in this study arm. |
| 100 gram OGTT | Active comparator | Behavioral: Dietary modification and medicationsA 2 step approach to the diagnosis of gestational diabetes will be used in this arm. Patients who have a 50 gram, 1 hour glucose challenge test result greater than 135 mg/dL will be diagnosed with gestational diabetes if their 3 hour, 100 gram OGTT results exceed the diagnostic threshold recommended by Carpenter and Coustan. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Plan to undergo gestational diabetes screening at 24-28 weeks' gestation.
Key exclusion criteria (8 listed)
- Existing Type 1 or Type 2 diabetes
- Diabetes diagnosed early in pregnancy (less than 24 weeks gestation)
- Multiple gestation (e.g. twins, triplets)
- Chronic hypertension (requiring medications)
- Oral, IM or IV corticosteroid use within the previous 30 days
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 |
|---|---|---|
| Dietary modification and medicationsPatients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control. | Behavioural | 100 gram OGTT, 75 Gram OGTT |
Primary outcome
Macrosomia
Time frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams
Cesarean delivery
Time frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Primary or repeat cesarean delivery
Diagnosis of gestational diabetes
Time frame: Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)
Assess how frequently a diagnosis of gestational diabetes is made
5 secondary outcomes
Pre-eclampsia or gestational hypertension
Time frame: Will be assessed from study enrollment until 30 days after delivery
Neonatal hypoglycemia
Time frame: First 24 hours of life
Neonatal hyperbilirubinemia
Time frame: First 7 days of life
Infant birth trauma
Time frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Maternal birth trauma
Time frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
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.
Christina M Scifres, MD principal investigator
University of Pittsburgh
Esa Davis, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary modification and medications in people with Gestational Diabetes, run by University of Pittsburgh 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 8 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: finished, as of the sponsor's last update on 4 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrosomia (time frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016.