N/A
Completed N=200
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Diabetes · Diagnoses Disease · Pregnancy in Diabetic · Glucose, High Blood
Source: ClinicalTrials.gov NCT04547023 ↗
Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Nov 2022
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.