Diabetes, GestationalGDMNCT00069576

Gestational Diabetes Mellitus Trial (GDM)

A study testing nutritional counseling and self blood glucose monitoring in people with Diabetes, Gestational, run by The George Washington University Biostatistics Center at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Diabetes, Gestational
What is being tested?: nutritional counseling and self blood glucose monitoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7,381 participants
Where: 16 sitesUnited States
Study dates: Oct 2002to Oct 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult

Who may be able to join

Pregnant
Gestational age at enrollment 24 - 31 weeks

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 17599
Northwestern University
Chicago, Illinois, 60611
Case Western Reserve University
Cleveland, Ohio, 44109
Ohio State University Hospital
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Wayne State University - Hutzel Hospital
Detroit, Michigan, 48201
University of Texas Medical Branch
Galveston, Texas, 77555
University of Texas-Houston
Houston, Texas, 77030
Columbia University-St. Luke's Hospital
New York, New York, 10032
Drexel University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
Brown University
Providence, Rhode Island, 02905
University of Utah
Salt Lake City, Utah, 84132
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in pregnant women. This study will determine whether treating pregnant women who have mild GDM improves the health of their babies. The follow-up study will examine whether factors during the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman and her child's health 4-9 years later.

Read the 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.

Conditions: Diabetes, Gestational
Being tested: nutritional counseling, self blood glucose monitoring
Keywords: Mild gestational diabetes mellitus, Maternal Fetal Medicine Units Network
Medical subject headings: Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nutritional counselingBehavioural
self blood glucose monitoringBehavioural

Study groups in NCT00069576
Study group	Role	What they receive
Nutritional counseling & self blood glucose monitoring	Active comparator	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. Receives: Behavioral: nutritional counseling; Behavioral: self blood glucose monitoring
No treatment	No intervention	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Composite Neonatal Morbidity
The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.
Measured: 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
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.
Measured: Age 5-10 years

Secondary outcomes (20)

Number of Neonates Who Were Large for Gestational Age at Delivery
Measured: From time of randomization through delivery (up to 17 weeks)
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
Measured: Assessed at Delivery
Number Participants Who Delivered Preterm
Number of preterm deliveries before 37 weeks gestation
Measured: Delivery before 37 weeks gestation
Mean Neonatal Fat Mass at Delivery
Measured: Assessed at delivery
Number of Neonates Who Were Small for Gestational Age
Birth weight below the 10th percentile
Measured: From time of randomization through delivery (up to 17 weeks)
Mean Neonatal Birth Weight
Birth weight in grams
Measured: Assessed at delivery
Number of Infants Admitted to NICU
Admission to the Neonatal Intensive Care Unit
Measured: Delivery through hospital discharge up to 120 days
Number of Neonates Who Received Intravenous Glucose Treatment
Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.
Measured: Delivery through hospital discharge up to 120 days
Number of Neonates Who Experienced Respiratory Distress Syndrome
Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge
Measured: Delivery through hospital discharge up to 120 days
Number of Participants Who Underwent Labor Induction
Number of participants who underwent labor induction
Measured: From time of randomization through induction (up to 17 weeks)
Number of Participants Who Underwent Cesarean Delivery
Delivery by cesarean section
Measured: Delivery
Number of Neonates Who Experienced Shoulder Dystocia
Number of neonates who experienced shoulder dystocia during labor and delivery
Measured: During the process of labor through delivery
Number of Participants Who Experienced Preeclampsia
Number of participants who experienced preeclampsia
Measured: From time of randomization through delivery (up to 17 weeks)
Number of Participants Who Had Preeclampsia or Gestational Hypertension
Number of participants who had Preeclampsia or gestational hypertension
Measured: From time of randomization through delivery (up to 17 weeks)
Mean Maternal Body-mass Index at Delivery
Mean maternal body-mass index at the time of delivery
Measured: Delivery
Mean Maternal Weight Gain
Mean Maternal weight gain from enrollment in the trial until delivery
Measured: From time of randomization through delivery (up to 17 weeks)
Number of Children With BMI ≥ 85th Percentile for Age and Sex
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.
Measured: Age 5-10 years
Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity
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)
Measured: Age 5-10 years
Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height
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.
Measured: Age 5 - 10 years
Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL
Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL
Measured: Age 5-10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Oct 2013

First posted30 Sep 2003 (estimated)
Study startOct 2002
Primary completionNov 2007
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7,381 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00069576
Sponsor's protocol ID: HD36801 - GDM
Other IDs: U10HD021410, U10HD027869, U10HD027917, U10HD027915, U10HD034116, U10HD034208, U10HD040500, U10HD040485
Acronym: GDM
Status last verified: Jul 2019
First submitted: 29 Sep 2003
Last updated: 15 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 12375675
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.
PubMed 21309194
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.
PubMed 21422852
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.
PubMed 22542118
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.
PubMed 22609018
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.
PubMed 23090528
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.
PubMed 23271384
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.
PubMed 23812458
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.
PubMed 23147078
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.
PubMed 24530820
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.
PubMed 24607755
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.
PubMed 24839145
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.
PubMed 25594222
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.
PubMed 26071920
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.
PubMed 26959208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes, Gestational trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
ClinicalTrials.gov ID: NCT00069576
Acronym / sponsor ID: GDM / HD36801 - GDM
Conditions: Diabetes, Gestational
Keywords: Mild gestational diabetes mellitus, Maternal Fetal Medicine Units Network
Study type: Interventional
Recruitment status: Completed
Enrolment: 7,381 participants (actual)
Lead sponsor: The George Washington University Biostatistics CenterUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Oct 2002
Primary completion: Nov 2007 (actual)
Study completion: Oct 2013 (actual)
First posted: 30 Sep 2003 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nutritional counseling & self blood glucose monitoring	Active comparator	Behavioral: nutritional counseling, Behavioral: self blood glucose monitoringWithin 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 treatment	No intervention	–This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Pregnant
Gestational age at enrollment 24 - 31 weeks

Key exclusion criteria (14 listed)

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

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
nutritional counseling	Behavioural	Nutritional counseling & self blood glucose monitoring
self blood glucose monitoring	Behavioural	Nutritional counseling & self blood glucose monitoring

Primary outcome

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.
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.

20 secondary outcomes

Number of Neonates Who Were Large for Gestational Age at Delivery
Time frame: From time of randomization through delivery (up to 17 weeks)
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
Time frame: Assessed at Delivery
Number Participants Who Delivered Preterm
Time frame: Delivery before 37 weeks gestation
Mean Neonatal Fat Mass at Delivery
Time frame: Assessed at delivery
Number of Neonates Who Were Small for Gestational Age
Time frame: From time of randomization through delivery (up to 17 weeks)
Mean Neonatal Birth Weight
Time frame: Assessed at delivery
Number of Infants Admitted to NICU
Time frame: 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 Experienced Respiratory Distress Syndrome
Time frame: 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 Cesarean Delivery
Time frame: Delivery
Number of Neonates Who Experienced Shoulder Dystocia
Time frame: 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 Had Preeclampsia or Gestational Hypertension
Time frame: From time of randomization through delivery (up to 17 weeks)
Mean Maternal Body-mass Index at Delivery
Time frame: Delivery
Mean Maternal Weight Gain
Time frame: 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 at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity
Time frame: 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
Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL
Time frame: Age 5-10 years

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nutritional Counseling & Self Blood Glucose Monitoring	485	460
No Treatment	473	440

Primary outcome: Number of Participants With Composite Neonatal Morbidity

Time frame: Delivery through discharge of infant from hospital up to 120 days. Count of participants. Unit: Participants

Measure	Nutritional Counseling & Self Blood Glucose Monitoring n = 485	No Treatment n = 473
Composite End Point Total	149	163
Hypoglycemia	62	55
Hyperbilirubinemia	43	54
Elevated cord-blood C-peptide level	75	92
Stillbirth or Neonatal Death	0	0
Birth Trauma	3	6

Nutritional Counseling & Self Blood Glucose Monitoring vs No Treatment: Risk Ratio (RR): 0.87 (97% CI 0.72 to 1.07), p = 0.14, Chi-squared
Nutritional Counseling & Self Blood Glucose Monitoring vs No Treatment: Risk Ratio (RR): 1.06 (97% CI 0.73 to 1.53), p = 0.75, Chi-squared
Nutritional Counseling & Self Blood Glucose Monitoring vs No Treatment: Risk Ratio (RR): 0.74 (97% CI 0.49 to 1.12), p = 0.12, Chi-squared

Population analysed: The results of some blood tests were not available either because samples were not obtained or were not obtained according to protocol or because they could not be assayed owing to a laboratory processing error. Data were not available in some cases because some women delivered at outside institutions.

Primary outcome: Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex

Time frame: Age 5-10 years. Count of participants. Unit: Participants

Measure	Nutritional Counseling & Self Blood Glucose Monitoring n = 264	No Treatment n = 236
Value	55	54

Nutritional Counseling & Self Blood Glucose Monitoring vs No Treatment: Risk Ratio (RR): 0.94 (95% CI 0.68 to 1.28)

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data on adverse events for the parent trial was collected from the time of randomization (as early as 24 weeks gestation), through delivery and up to hospital discharge of the infant, death of the infant or 120 days if still hospitalized. Data on adverse events for the follow-up study was collected at the time of the study visit when the child(ren) of the participants were 5-10 years of age.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nutritional Counseling & Self Blood Glucose Monitoring	0 of 485 (0%)	0 of 485 (0%)	Not reported
No Treatment	0 of 473 (0%)	0 of 473 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12375675Landon 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.
Background: PubMed 21309194Landon 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.
Background: PubMed 21422852Durnwald 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.
Background: PubMed 22542118Bahado-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.
Background: PubMed 22609018Stuebe 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.
Background: PubMed 23090528Berggren 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.
Background: PubMed 23271384Ma 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.
Background: PubMed 23812458Figueroa 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.
Background: PubMed 23147078Costantine 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.
Background: PubMed 24530820Catalano 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.
Background: PubMed 24607755Sutton 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.
Background: PubMed 24839145Casey 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.
NICHD Maternal Fetal Medicine Units Network websiteLink provided by the sponsor.

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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.

Mark B. Landon, MD study chair

Ohio State University

Uma Reddy, MD, MPH study director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Elizabeth A Thom, Ph.D. principal investigator

George Washington University Biostatistics Center

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Composite Neonatal Morbidity (time frame: Delivery through discharge of infant from hospital up to 120 days). The study lists 2 primary outcomes in all. 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 NCT00069576, which also lists 23 linked publications.

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 15 Jul 2019.