N/A N=958 Randomized Treatment

Gestational Diabetes Mellitus Trial (GDM)

Diabetes, Gestational

Bottom Line

View on ClinicalTrials.gov: NCT00069576 ↗

Enrolled (actual)

958

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Number of Participants With Composite Neonatal Morbidity — 149; 163; 62; 55 Participants — p=0.14

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: nutritional counseling (Behavioral); self blood glucose monitoring (Behavioral)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: The George Washington University Biostatistics Center
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Composite Neonatal Morbidity	149; 163; 62; 55; 43; 54	0.14
PRIMARY Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex	55; 54	—
SECONDARY Number of Neonates Who Were Large for Gestational Age at Delivery	34; 66	<0.001 sig
SECONDARY Number of Neonates With Macrosomia (Birth Weight > 4000 gm)	28; 65	<0.001 sig
SECONDARY Number Participants Who Delivered Preterm	45; 53	0.27
SECONDARY Mean Neonatal Fat Mass at Delivery	427.0; 464.3	0.003 sig
SECONDARY Number of Neonates Who Were Small for Gestational Age	36; 29	0.49
SECONDARY Mean Neonatal Birth Weight	3302; 3408	<0.001 sig
SECONDARY Number of Infants Admitted to NICU	43; 53	0.19
SECONDARY Number of Neonates Who Received Intravenous Glucose Treatment	25; 31	0.32
SECONDARY Number of Neonates Who Experienced Respiratory Distress Syndrome	9; 13	0.33
SECONDARY Number of Participants Who Underwent Labor Induction	130; 122	0.86
SECONDARY Number of Participants Who Underwent Cesarean Delivery	128; 154	0.02 sig
SECONDARY Number of Neonates Who Experienced Shoulder Dystocia	7; 18	0.02 sig
SECONDARY Number of Participants Who Experienced Preeclampsia	12; 25	0.02 sig
SECONDARY Number of Participants Who Had Preeclampsia or Gestational Hypertension	41; 62	0.01 sig
SECONDARY Mean Maternal Body-mass Index at Delivery	31.3; 32.3	<0.001 sig
SECONDARY Mean Maternal Weight Gain	2.8; 5.0	<0.001 sig
SECONDARY Number of Children With BMI ≥ 85th Percentile for Age and Sex	86; 91	—
SECONDARY Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity	31; 27	—
SECONDARY Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height	30; 23	—
SECONDARY Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL	12; 13	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00069576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.