N/A N=95 Randomized Treatment

Early Screening and Treatment of Women With Prediabetes in Pregnancy

Diabetes · Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT01552213 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Jan 2019

Primary outcome: Primary: Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation. — 19; 23 Participants — p=0.32

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Minimum intervention control group (Other); Treatment for glucose intolerance (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.	19; 23	0.32
SECONDARY Number of Participants With Different Modes of Delivery	11; 17; 26; 19; 0; 1	0.32
SECONDARY Number of Participants With Excessive Gestational Weight Gain	6; 6	0.96
SECONDARY Mean Hemoglobin A1C Value at Delivery	5.5; 5.8	0.01 sig
SECONDARY Mean Fasting Triglyceride Level	181; 177.5	0.75
SECONDARY Number of Patients With Gestational Hypertension	3; 3	0.95
SECONDARY Number of Patients With Pre-eclampsia	2; 2	0.5
SECONDARY Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum	115.8; 108.9	0.6
SECONDARY Number of Participants With Need for Insulin Therapy	14; 10	0.36
SECONDARY Mean Neonatal Birth Weight	3218; 3322	0.42
SECONDARY Mean Ponderal Index	2.5; 2.5	0.5
SECONDARY Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort	3; 1	0.46
SECONDARY Number of Participants With Neonatal Hypoglycemia	2; 2	1
SECONDARY Number of Participants With Neonatal Hyperbilirubinemia	9; 6	0.56
SECONDARY Number of Participants With Intrauterine Fetal Demise	0; 1	—

Summary

The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and diabetes in this country even among young women and the adverse affects of diabetes of pregnant women and their infants, the investigators feel that it is important to not only identify women at high risk for diabetes early in pregnancy but determine the appropriate management strategy

Eligibility Criteria

Inclusion Criteria

Age 18 or older
Singleton pregnancy
Prenatal care established at less than 14 weeks
A1C 5.7-6.4%
Delivery planned at Lucille Packard Children's Hospital at Stanford University (LPCH) or Santa Clara Valley Medical Center (SVMC)

Exclusion Criteria

preexisting diabetes or chronic steroid use
known major fetal anomalies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01552213). 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.