- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069576
Gestational Diabetes Mellitus Trial (GDM) (GDM)
A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gestational diabetes mellitus is defined as glucose intolerance of variable severity with onset or first recognition during pregnancy. The definition applies regardless of insulin use for treatment or the persistence of the condition after pregnancy, and does not exclude the possibility that unrecognized glucose intolerance or overt diabetes may have preceded the pregnancy. Pre-existing diabetes substantially contributes to perinatal morbidity and mortality. The association of milder forms of gestational diabetes with adverse pregnancy outcomes, including morbidities such as macrosomia, birth trauma, and neonatal hypoglycemia, remains questionable. While it is likely that maternal glucose intolerances reflect a continuum of risk for adverse outcomes, it is not known whether there is a benefit to identification and subsequent treatment of mild glucose intolerance during pregnancy. This study will determine whether dietary treatment (and insulin as required) for mild GDM will reduce the frequency of neonatal morbidity associated with mild glucose intolerance.
Participants in this study will receive a 50-gram glucose loading test (GLT) between 24 and 30 weeks' gestation. Those with a positive GLT will receive a subsequent 3-hour oral glucose tolerance test (OGTT). Based upon these test results, women will be assigned to 4 groups. Women with a positive GLT and abnormal OGTT will be randomly assigned to receive either nutritional counseling and diet therapy (Group 1) or no specific treatment (Group 2a). Women with a positive GLT but normal OGTT will be enrolled in Group 2b for observation. Women with a negative GLT will be enrolled in Group 3 and will serve as a control group.
Women in Group 1 will receive formal nutritional counseling and will be instructed on the techniques of self blood glucose monitoring. Patients will take daily blood glucose measurements and will be seen at weekly study visits. The study will evaluate birth outcomes, including stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal hyperbilirubinemia, and birth trauma.
The follow-up study will examine if blood sugar levels and treatments during pregnancy influence the health of the mother and child several years later. The study will also examine whether there is a genetic link to the health of the mother and child. The study visit will include blood pressure, body size measurements, blood draw and saliva collection, and questions related to the mother and child's health and environment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University - Hutzel Hospital
-
-
New York
-
New York, New York, United States, 10032
- Columbia University-St. Luke's Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 17599
- University of North Carolina-Chapel Hill
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University School of Medicine
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- Case Western Reserve University
-
Columbus, Ohio, United States, 43210
- Ohio State University Hospital
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Drexel University
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh-Magee Womens Hospital
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Brown University
-
-
Texas
-
Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center
-
Galveston, Texas, United States, 77555
- University of Texas Medical Branch
-
Houston, Texas, United States, 77030
- University of Texas-Houston
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant
- Gestational age at enrollment 24 - 31 weeks
Exclusion Criteria:
- Diabetes diagnosed prior to pregnancy
- Abnormal gestational diabetes (>= 135 mg/dl) testing prior to 24 weeks' gestation
- Gestational diabetes in a previous pregnancy
- History of stillbirth or fetal death
- Pregnancy with more than one fetus
- Known major fetal anomaly
- Current or planned corticosteroid therapy
- Asthma requiring medication
- Current or planned beta adrenergic therapy
- Chronic hypertension requiring medication within 6 months of or during pregnancy
- Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
- Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
- Maternal or fetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labor, or intrauterine growth retardation
- Previous or planned tocolytic therapy to induce labor or increase contraction strength
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nutritional counseling & self blood glucose monitoring
Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.
|
|
|
No Intervention: No treatment
This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Composite Neonatal Morbidity
Time Frame: Delivery through discharge of infant from hospital up to 120 days
|
The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.
|
Delivery through discharge of infant from hospital up to 120 days
|
|
Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex
Time Frame: Age 5-10 years
|
Number of children with BMI ≥ 95th percentile for age and sex.
BMI is measured as kg / m^2.
Standards based on the 2000 Centers for Disease Control growth charts.
|
Age 5-10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Neonates Who Were Large for Gestational Age at Delivery
Time Frame: From time of randomization through delivery (up to 17 weeks)
|
From time of randomization through delivery (up to 17 weeks)
|
|
|
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
Time Frame: Assessed at Delivery
|
Assessed at Delivery
|
|
|
Number Participants Who Delivered Preterm
Time Frame: Delivery before 37 weeks gestation
|
Number of preterm deliveries before 37 weeks gestation
|
Delivery before 37 weeks gestation
|
|
Mean Neonatal Fat Mass at Delivery
Time Frame: Assessed at delivery
|
Assessed at delivery
|
|
|
Number of Neonates Who Were Small for Gestational Age
Time Frame: From time of randomization through delivery (up to 17 weeks)
|
Birth weight below the 10th percentile
|
From time of randomization through delivery (up to 17 weeks)
|
|
Mean Neonatal Birth Weight
Time Frame: Assessed at delivery
|
Birth weight in grams
|
Assessed at delivery
|
|
Number of Infants Admitted to NICU
Time Frame: Delivery through hospital discharge up to 120 days
|
Admission to the Neonatal Intensive Care Unit
|
Delivery through hospital discharge up to 120 days
|
|
Number of Neonates Who Received Intravenous Glucose Treatment
Time Frame: Delivery through hospital discharge up to 120 days
|
Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.
|
Delivery through hospital discharge up to 120 days
|
|
Number of Neonates Who Experienced Respiratory Distress Syndrome
Time Frame: Delivery through hospital discharge up to 120 days
|
Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge
|
Delivery through hospital discharge up to 120 days
|
|
Number of Participants Who Underwent Labor Induction
Time Frame: From time of randomization through induction (up to 17 weeks)
|
Number of participants who underwent labor induction
|
From time of randomization through induction (up to 17 weeks)
|
|
Number of Participants Who Underwent Cesarean Delivery
Time Frame: Delivery
|
Delivery by cesarean section
|
Delivery
|
|
Number of Neonates Who Experienced Shoulder Dystocia
Time Frame: During the process of labor through delivery
|
Number of neonates who experienced shoulder dystocia during labor and delivery
|
During the process of labor through delivery
|
|
Number of Participants Who Experienced Preeclampsia
Time Frame: From time of randomization through delivery (up to 17 weeks)
|
Number of participants who experienced preeclampsia
|
From time of randomization through delivery (up to 17 weeks)
|
|
Number of Participants Who Had Preeclampsia or Gestational Hypertension
Time Frame: From time of randomization through delivery (up to 17 weeks)
|
Number of participants who had Preeclampsia or gestational hypertension
|
From time of randomization through delivery (up to 17 weeks)
|
|
Mean Maternal Body-mass Index at Delivery
Time Frame: Delivery
|
Mean maternal body-mass index at the time of delivery
|
Delivery
|
|
Mean Maternal Weight Gain
Time Frame: From time of randomization through delivery (up to 17 weeks)
|
Mean Maternal weight gain from enrollment in the trial until delivery
|
From time of randomization through delivery (up to 17 weeks)
|
|
Number of Children With BMI ≥ 85th Percentile for Age and Sex
Time Frame: Age 5-10 years
|
Number of children with BMI ≥ 85th percentile for age and sex at the 5-10 year follow-up.
BMI is measured as kg/m^2.
Standards base on the 2000 Centers for Disease Control growth charts.
|
Age 5-10 years
|
|
Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity
Time Frame: Age 5-10 years
|
Child waist circumference >90th percentile for age, sex and race/ethnicity based on a study examining cross-sectional data from the Third National Health and Nutrition Examination Survey (NHANES III)
|
Age 5-10 years
|
|
Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height
Time Frame: Age 5 - 10 years
|
Hypertension ≥ 95th percentile for age, sex and height based on the National Heart, Lung and Blood Institute Expert Panel on Integrated Guidelines for Children and Adolescents.
|
Age 5 - 10 years
|
|
Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL
Time Frame: Age 5-10 years
|
Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL
|
Age 5-10 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Gestational Age at Birth
Time Frame: Delivery
|
Mean Gestational age at the time of delivery
|
Delivery
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Mark B. Landon, MD, Ohio State University
- Study Director: Uma Reddy, MD, MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications and helpful links
General Publications
- Catalano PM, Mele L, Landon MB, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Saade G, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Inadequate weight gain in overweight and obese pregnant women: what is the effect on fetal growth? Am J Obstet Gynecol. 2014 Aug;211(2):137.e1-7. doi: 10.1016/j.ajog.2014.02.004. Epub 2014 Feb 11.
- Landon MB, Thom E, Spong CY, Gabbe SG, Leindecker S, Johnson F, Lain K, Miodovnik M, Carpenter M. A planned randomized clinical trial of treatment for mild gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2002 Apr;11(4):226-31. doi: 10.1080/jmf.11.4.226.231.
- Landon MB, Mele L, Spong CY, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health, and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. The relationship between maternal glycemia and perinatal outcome. Obstet Gynecol. 2011 Feb;117(2 Pt 1):218-224. doi: 10.1097/AOG.0b013e318203ebe0.
- Durnwald CP, Mele L, Spong CY, Ramin SM, Varner MW, Rouse DJ, Sciscione A, Catalano P, Saade G, Sorokin Y, Tolosa JE, Casey B, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Glycemic characteristics and neonatal outcomes of women treated for mild gestational diabetes. Obstet Gynecol. 2011 Apr;117(4):819-827. doi: 10.1097/AOG.0b013e31820fc6cf.
- Bahado-Singh RO, Mele L, Landon MB, Ramin SM, Carpenter MW, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-fetal Medicine Units Network. Fetal male gender and the benefits of treatment of mild gestational diabetes mellitus. Am J Obstet Gynecol. 2012 May;206(5):422.e1-5. doi: 10.1016/j.ajog.2012.03.015. Epub 2012 Mar 23.
- Stuebe AM, Landon MB, Lai Y, Spong CY, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Harper M, Saade G, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, MD. Maternal BMI, glucose tolerance, and adverse pregnancy outcomes. Am J Obstet Gynecol. 2012 Jul;207(1):62.e1-7. doi: 10.1016/j.ajog.2012.04.035. Epub 2012 May 2.
- Berggren EK, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Perinatal outcomes in Hispanic and non-Hispanic white women with mild gestational diabetes. Obstet Gynecol. 2012 Nov;120(5):1099-104. doi: 10.1097/aog.0b013e31827049a5.
- Ma KK, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The obstetric and neonatal implications of a low value on the 50-g glucose screening test. Am J Perinatol. 2013 Oct;30(9):715-22. doi: 10.1055/s-0032-1331027. Epub 2012 Dec 27.
- Figueroa D, Landon MB, Mele L, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Relationship between 1-hour glucose challenge test results and perinatal outcomes. Obstet Gynecol. 2013 Jun;121(6):1241-1247. doi: 10.1097/AOG.0b013e31829277f5.
- Costantine MM, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Maryland. Customized versus population approach for evaluation of fetal overgrowth. Am J Perinatol. 2013 Aug;30(7):565-72. doi: 10.1055/s-0032-1329188. Epub 2012 Nov 12.
- Sutton AL, Mele L, Landon MB, Ramin SM, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Grobman WA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Delivery timing and cesarean delivery risk in women with mild gestational diabetes mellitus. Am J Obstet Gynecol. 2014 Sep;211(3):244.e1-7. doi: 10.1016/j.ajog.2014.03.005. Epub 2014 Mar 4.
- Casey BM, Mele L, Landon MB, Spong CY, Ramin SM, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Catalano P, Harper M, Saade G, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Does maternal body mass index influence treatment effect in women with mild gestational diabetes? Am J Perinatol. 2015 Jan;32(1):93-100. doi: 10.1055/s-0034-1374815. Epub 2014 May 16.
- Stuebe AM, Landon MB, Lai Y, Klebanoff M, Ramin SM, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Saade G, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, MD. Is There a Threshold Oral Glucose Tolerance Test Value for Predicting Adverse Pregnancy Outcome? Am J Perinatol. 2015 Jul;32(9):833-8. doi: 10.1055/s-0034-1543949. Epub 2015 Jan 16.
- Palatnik A, Mele L, Landon MB, Reddy UM, Ramin SM, Carpenter MW, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Saade GR, Caritis SN, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes. Am J Obstet Gynecol. 2015 Oct;213(4):560.e1-8. doi: 10.1016/j.ajog.2015.06.022. Epub 2015 Jun 11.
- Rice MM, Landon MB, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Biggio JR Jr, Thorp JM Jr, Chien EK, Saade G, Peaceman AM, Blackwell SC, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Pregnancy-Associated Hypertension in Glucose-Intolerant Pregnancy and Subsequent Metabolic Syndrome. Obstet Gynecol. 2016 Apr;127(4):771-779. doi: 10.1097/AOG.0000000000001353.
- Harper LM, Mele L, Landon MB, Carpenter MW, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol. 2016 May;127(5):893-898. doi: 10.1097/AOG.0000000000001383.
- Blackwell SC, Landon MB, Mele L, Reddy UM, Casey BM, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Saade G, Caritis SN, Sorokin Y, Grobman WA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Relationship Between Excessive Gestational Weight Gain and Neonatal Adiposity in Women With Mild Gestational Diabetes Mellitus. Obstet Gynecol. 2016 Dec;128(6):1325-1332. doi: 10.1097/AOG.0000000000001773.
- Varner MW, Rice MM, Landon MB, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Tita ATN, Thorp JM, Chien EK, Saade GR, Peaceman AM, Blackwell SC, Vandorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Pregnancies After the Diagnosis of Mild Gestational Diabetes Mellitus and Risk of Cardiometabolic Disorders. Obstet Gynecol. 2017 Feb;129(2):273-280. doi: 10.1097/AOG.0000000000001863.
- Tita ATN, Lai Y, Landon MB, Ramin SM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade GR, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol. 2017 Dec;34(14):1464-1469. doi: 10.1055/s-0037-1604243. Epub 2017 Jul 19.
- Landon MB, Rice MM, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Biggio JR Jr, Thorp JM, Chien EK, Saade G, Peaceman AM, Blackwell SC, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Mild gestational diabetes mellitus and long-term child health. Diabetes Care. 2015 Mar;38(3):445-52. doi: 10.2337/dc14-2159. Epub 2014 Nov 20.
- Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
- Durnwald C, Mele L, Landon MB, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Tita ATN, Thorp JM Jr, Chien EK, Saade GR, Peaceman AM, Blackwell SC; Eunice Kennedy Shriver National Institute of Child Health Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network. Fibroblast Growth Factor 21 and Metabolic Dysfunction in Women with a Prior Glucose-Intolerant Pregnancy. Am J Perinatol. 2021 Nov;38(13):1380-1385. doi: 10.1055/s-0040-1712966. Epub 2020 Jun 23.
- Rice MM, Landon MB, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Tita ATN, Thorp JM Jr, Chien EK, Saade G, Peaceman AM, Blackwell SC; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Pregnancy-Associated Hypertension and Offspring Cardiometabolic Health. Obstet Gynecol. 2018 Feb;131(2):313-321. doi: 10.1097/AOG.0000000000002433.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD36801 - GDM
- U10HD036801 (U.S. NIH Grant/Contract)
- U10HD021410 (U.S. NIH Grant/Contract)
- U10HD027869 (U.S. NIH Grant/Contract)
- U10HD027917 (U.S. NIH Grant/Contract)
- U10HD027860 (U.S. NIH Grant/Contract)
- U10HD034116 (U.S. NIH Grant/Contract)
- U10HD034208 (U.S. NIH Grant/Contract)
- U10HD034136 (U.S. NIH Grant/Contract)
- U10HD040500 (U.S. NIH Grant/Contract)
- U10HD040485 (U.S. NIH Grant/Contract)
- U10HD040544 (U.S. NIH Grant/Contract)
- U10HD040545 (U.S. NIH Grant/Contract)
- U10HD040560 (U.S. NIH Grant/Contract)
- U10HD040512 (U.S. NIH Grant/Contract)
- U10HD053097 (U.S. NIH Grant/Contract)
- U10HD027915 (U.S. NIH Grant/Contract)
- U10HD053118 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes, Gestational
-
IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
-
UPECLIN HC FM Botucatu UnespCompletedGestational Diabetes Mellitus | Pregestational Diabetes Mellitus | Mild Gestational HyperglycemiaBrazil
-
Royal College of Surgeons, IrelandHealth Research Board - Trials Methodology Research NetworkCompletedPre-Gestational DiabetesIreland
-
University of Texas Southwestern Medical CenterCompletedMild Gestational DiabetesUnited States
-
University of Colorado, DenverKaiser PermanenteCompletedGestational Diabetes MellitusUnited States
-
Intermountain Health Care, Inc.Withdrawn
-
University of Tennessee Graduate School of MedicineRecruitingInsulin Resistance | Pregnancy Complications | Pregnancy | Preeclampsia | Gestational Diabetes | Gestational Diabetes Mellitus in Pregnancy | Placental Dysfunction | Gestational Diabetes Mellitus (GDM) | Preeclampsia (PE) | Cardiometabolic Diseases | Gestational Complications | Preeclampsia (PE) RiskUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingPregnancy Complications | Gestational Diabetes Mellitus (GDM) | Diabetes During Pregnancy | Pregnancy in Diabetes | Gestational | Diabetes ComplicationPakistan
-
Woman'sBaton Rouge Area FoundationCompletedGestational Diabetes MellitusUnited States
-
Baylor College of MedicineRecruitingGestational Diabetes MellitusUnited States
Clinical Trials on nutritional counseling
-
Charite University, Berlin, GermanyCompletedIBS - Irritable Bowel SyndromeGermany
-
King Edward Medical UniversityActive, not recruitingCachexia; Cancer; SarcopeniaPakistan
-
Hospital de Clinicas de Porto AlegreActive, not recruitingBinge-Eating Disorder | Cognitive Behavioral Therapy | Transcranial Direct Current StimulationBrazil
-
University of PadovaFondazione Guido Berlucchi; Veneto Institute of Oncology I.O.V.-I.R.C.C.S.Terminated
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCancer SurvivorUnited States
-
William Carey UniversityUniversity of Mississippi Medical Center; University of Southern MississippiCompletedSpinal Cord InjuriesUnited States
-
Société des Produits Nestlé (SPN)CompletedPicky Eating BehaviorsChina
-
Emanuele CeredaCompletedNutritional SupportItaly
-
Montefiore Medical CenterRecruiting
-
Medical University of GrazRecruitingDepressive Disorder | Sleep | Psychological Stress | Nutritional Quality | Burn-out SyndromeAustria