Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD079647 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.
Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indication of long-term metabolic dysfunction leading to diabetes and cardiovascular disease. In the US, GDM is diagnosed using a two-step screening and diagnostic approach. The International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed a one-step diagnostic approach that broadens the definition of GDM by lowering the cutoff values to include women with milder forms of hyperglycemia, who would have screened normal under the current two-step approach. The goal of these recommendations is better identification of women at risk for pregnancy complications and long-term metabolic dysfunction, but it results in a significant increase in the prevalence of GDM. The NIH GDM Consensus Development Conference committee does not recommend changing from the current two-step screening/diagnostic approach to the IADPSG one-step diagnostic approach without trials demonstrating that increasing the number of women diagnosed as having GDM results in better outcomes. We aim to 1) conduct a "real world" randomized controlled trial (RCT) to determine differences in short-term perinatal health outcomes between the two predominant GDM screening approaches, and 2) prospectively follow the mothers to examine their metabolic risk profiles and the growth of their infants at 1 year postpartum. Based on a pilot study, we propose a single site blinded RCT of 920 pregnant women ages 18-45 years without a diagnosis of diabetes, with a singleton pregnancy (18-24 wks gestation). Participants will have a non-fasting 1 hour 50 gm glucose challenge test (GCT) performed between 24-28 weeks' gestation. Women with 50 gm GCT results < 200 mg/dL will be randomized to receive either a fasting 2 hour 75 gm oral glucose tolerance test (OGTT) or a 3 hour 100 gm OGTT. GDM will be diagnosed using the IADPSG criteria for women receiving the 75 gm OGTT and Carpenter-Coustan criteria for women receiving the 100 gm. Participants and their physicians will be informed of the diagnosis of GDM, but blinded to the specific test results and diagnostic criteria. Participants with GDM will receive treatment from their primary provider. Questionnaires will be used to assess participants' and physicians' views on GDM testing. Metabolic profiles will be assessed at randomization and at a year postpartum. The primary outcome measure is large-for-gestational age fetal growth. The rationale for this RCT is that this is a unique opportunity to compare the two methods. At the end of the study, we will know whether women diagnosed at lower glucose levels with the IADPSG criteria are more likely to have adverse perinatal outcomes. We hypothesize that using IADPSG diagnostic criteria will result in greater detection of women with impaired glucose metabolism and treating these women will reduce adverse perinatal outcomes and prevent long-term metabolic dysfunction. This study will provide level A data for endorsing universal screening guidelines for GDM by major organizations and implementation into clinical care.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 hour 100 gm OGTT (CC Criteria) | Active Comparator | Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. |
|
| 2 hr 75 gm OGTT (IADPSG Criteria) | Active Comparator | Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gestational diabetes screening with fasting 3 hour 100 gm | Diagnostic Test | Participants receive fasting 3 hour 100 gm oral glucose tolerance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Large for Gestational Age (LGA) Infant | birth weight equal to or greater than the 90th percentile for gestational age and sex | at time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Delivery | the delivery of a baby through a surgical incision in the mother's abdomen and uterus | at delivery (approximately 40 weeks' gestation) |
| Maternal Composite Morbidity | maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esa M Davis, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC- Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28823926 | Background | Abebe KZ, Scifres C, Simhan HN, Day N, Catalano P, Bodnar LM, Costacou T, Matthew D, Illes A, Orris S, Duell J, Ly K, Davis EM. Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18. | |
| 39159865 | Derived | Scifres CM, Davis EM, Orris S, Costacou T, Lalama C, Abebe KZ, Catalano P. Metabolic factors and perinatal outcomes among pregnant individuals with mild glucose intolerance. Diabetes Res Clin Pract. 2024 Oct;216:111830. doi: 10.1016/j.diabres.2024.111830. Epub 2024 Aug 17. |
Not provided
Not provided
Once the study is completed and the investigators have published the main manuscripts regarding the outcomes of the trial. De-identified data will be made available by request, review and approval of the investigators and the institution regulatory committee.
Data will be shared in the appropriate time frame required by policy.
An application and review process will be implemented for accessing data.
Not provided
Not provided
Pregnant women were recruited from June 2015 to February 2019 from 10 obstetrical clinics affiliated with Magee Women's Hospital in Pittsburgh,Pennsylvania
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 3 Hour 100 gm OGTT (CC Criteria) | Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test |
| FG001 | 2 hr 75 gm OGTT (IADPSG Criteria) | Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the International Association of the Diabetes in Pregnancy Study Group (IADPSG) which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 3 Hour 100 gm OGTT (CC Criteria) | Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Large for Gestational Age (LGA) Infant | birth weight equal to or greater than the 90th percentile for gestational age and sex | Posted | Count of Participants | Participants | at time of delivery |
|
Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Hour 100 gm OGTT (CC Criteria) | Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | < 40-30 mg/dl; <2.2-1.7 mol/L |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Metabolism and nutrition disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Center for Research on Health Care Data Center | University of Pittsburgh | 412-692-2023 | dcenter@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2020 | Jul 1, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 1, 2019 | Jul 1, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gestational diabetes screening with fasting 2 hour 75g | Diagnostic Test | Participants receive fasting 2 hour 75 gm oral glucose tolerance test |
|
| at delivery (approximately 40 weeks' gestation) |
| Neonatal Composite Morbidity | 1) hypoglycemia: blood glucose < 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries. | 7 days after birth |
| 34259458 | Derived | Davis EM, Abebe KZ, Simhan HN, Catalano P, Costacou T, Comer D, Orris S, Ly K, Decker A, Mendez D, Day N, Scifres CM. Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jul 1;138(1):6-15. doi: 10.1097/AOG.0000000000004431. |
| delivered before visit 2 |
|
| BG001 | 2 hr 75 gm OGTT (IADPSG Criteria) | Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| pre-pregnancy BMI | participant data missing | Mean | Standard Deviation | kg/m2 |
|
| Glucose Challenge 50 gm test | Mean | Standard Deviation | mg/dl |
|
| previous history of gestational diabetes | participant missing data | Count of Participants | Participants |
|
| First degree family history of diabetes | participant missing data | Count of Participants | Participants |
|
| OG003 | Carpenter Coustan With no GDM | Participants diagnosed as having no GDM by the Carpenter Coustan criteria |
|
|
|
| Secondary | Cesarean Delivery | the delivery of a baby through a surgical incision in the mother's abdomen and uterus | Posted | Count of Participants | Participants | at delivery (approximately 40 weeks' gestation) |
|
|
|
|
| Secondary | Maternal Composite Morbidity | maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage | Posted | Count of Participants | Participants | at delivery (approximately 40 weeks' gestation) |
|
|
|
|
| Secondary | Neonatal Composite Morbidity | 1) hypoglycemia: blood glucose < 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries. | Posted | Count of Participants | Participants | 7 days after birth |
|
|
|
|
| 0 |
| 460 |
| 17 |
| 460 |
| 154 |
| 460 |
| EG001 | 2 hr 75 gm OGTT (IADPSG Criteria) | Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test | 0 | 461 | 2 | 461 | 56 | 461 |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | < 30 mg/dl; <1.7 mol/L, life threatening consequences; seizures |
|
| migraine headache | Nervous system disorders | Systematic Assessment | went to Emergency room and as tx and released. |
|
| heavy vaginal bleeding | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Admitted to hospital with vaginal bleeding due to placenta previa |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pt had spontaneous premature rupture of members right during study visit |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Other | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
Not provided
Not provided
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Risk Ratio (RR) |
| 1.033 |
| 2-Sided |
| 95 |
| 0.816 |
| 1.307 |
| Superiority |
| Risk Ratio (RR) |
| 1.022 |
| 2-Sided |
| 95 |
| 0.742 |
| 1.407 |
| Superiority |
| Risk Ratio (RR) |
| 1.233 |
| 2-Sided |
| 95 |
| 0.864 |
| 1.760 |
| Superiority |