N/A
N=200
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Gestational Diabetes · Diagnoses Disease · Pregnancy in Diabetic · Glucose, High Blood
Bottom Line
View on ClinicalTrials.gov: NCT04547023 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT) — 31; 13 Participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fasting before gestational diabetes screen (Behavioral); Per oral intake of food and drink (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT) |
31; 13 | 0.002 sig |
| SECONDARY Mean Gestational Age at OGTT Screen |
25.7; 25.8 | — |
| SECONDARY Mean Glucose Level at the OGTT Screen |
127.7; 113.3 | — |
| SECONDARY Number of Participants With Positive GDM Diagnosis Based on the OGTT |
8; 2 | — |
| SECONDARY Average Time of Last Oral Intake Prior to the OGTT Screen |
10.7; 1.4 | — |
| SECONDARY Number of Participants With Positive GDM Diagnosis |
12; 5 | — |
| SECONDARY Mean Gestational Age at Delivery |
272; 272 | — |
| SECONDARY Number of Participants Who Delivered Vaginally |
67; 53 | — |
| SECONDARY Number of Participants Who Delivered Via Operative Vaginal Birth |
3; 7 | — |
| SECONDARY Number of Participants Who Delivered Vaginally After a Prior Cesarean Section |
2; 1 | — |
| SECONDARY Number of Participants Who Delivered Via a Primary Cesarean Section |
17; 21 | — |
| SECONDARY Number of Participants Who Delivered Via a Repeat Cesarean Section |
7; 14 | — |
| SECONDARY Number of Participants Complicated by Shoulder Dystocia at Delivery |
0; 1 | — |
| SECONDARY Number of Participants Complicated by Third or Fourth Degree Perineal Laceration |
2; 4 | — |
| SECONDARY Number of Participants With Post-partum Hemorrhage |
16; 10 | — |
| SECONDARY Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy |
22; 15 | — |
| SECONDARY Length of Postnatal Stay From Delivery to Discharge |
2.3; 2.4 | — |
| SECONDARY Number of Participants Who Had a Postpartum Readmission |
4; 6 | — |
| SECONDARY Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum |
1; 0 | — |
| SECONDARY Mean Neonatal Birthweight |
3231; 3268 | — |
| SECONDARY Number of Neonates With Birth Weight More Than 4000 Grams |
6; 6 | — |
| SECONDARY Number of Neonates Considered Large for Gestational Age (LGA) |
6; 7 | — |
| SECONDARY Number of Neonates Considered Small for Gestational Age (SGA) |
6; 9 | — |
| SECONDARY Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU) |
4; 7 | — |
| SECONDARY Number of Neonates With Hyperbilirubinemia |
7; 9 | — |
| SECONDARY Number of Neonates With Hypoglycemia |
9; 5 | — |
| SECONDARY Number of Neonates Diagnosed With Respiratory Distress Syndrome |
7; 7 | — |
| SECONDARY Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge |
62; 59 | — |
Summary
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.
Eligibility Criteria
Inclusion Criteria
- Pregnant patients 18 years and older
- Singleton gestation
- Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
- Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
Exclusion Criteria
- Pregestational diabetes
- Gestational diabetes diagnosed in the 1st trimester
- Less than 18 years of age
- Planned delivery outside LPCH
- Diabetes medication use prior to pregnancy
- Inability to give informed consent
- Chronic steroid use in pregnancy
- Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
- Prior history of bariatric surgery
- Multifetal gestation
Data sourced from ClinicalTrials.gov (NCT04547023). 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.