An interventional study of Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. in Pregnancy - Prenatal Testing, sponsored by Bnai Zion Medical Center. Enrolling by invitation at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Screening
Study Type: Observational, prospective, multicenter comparative study
Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation.
Main Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Comparison Group:
Researchers will compare the standard GCT (50g glucola drink) with the alternative GCT (500 ml grape juice containing 50g sugar). Each participant will undergo both tests, serving as her own control, to assess differences in glucose measurements and patient preferences.
Participant Tasks:
Participants will:
- Undergo two glucose challenge tests (GCT): Standard GCT (50g glucola) at their health maintenance organization (HMO) or hospital.
Alternative GCT (500 ml grape juice) during a scheduled visit or hospitalization.
Study Type: Prospective, observational, multicenter comparative study Primary Purpose: To evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening, with the goal of improving patient compliance and satisfaction.
Participant Population: Pregnant individuals at 24-28 weeks of gestation, undergoing routine glucose challenge testing (GCT). Participants will be recruited from Maternal-Fetal Medicine (MFM) clinics, prenatal maternal wards, and social media outreach.
Main Research Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Study Design \& Methods:
Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar).
Control Group: Each participant serves as her own control by completing both tests in a randomized order.
Blood Glucose Measurement: A blood sample will be drawn one hour after ingestion of each drink to compare glucose levels.
Follow-up: If necessary, follow-up phone calls will be conducted to collect results from the standard GCT performed at external clinics.
Outcome Measures:
Primary Outcomes:
Mean difference in blood glucose levels between the standard and alternative GCT.
Proportion of patients with a positive screening result (≥140 mg/dL) for both methods.
Sensitivity, specificity, and predictive values of the alternative GCT compared to the standard test.
Agreement between the two methods using Bland-Altman analysis.
Secondary Outcomes:
Patient satisfaction with both screening methods (measured via a Likert scale). Participant preference between grape juice and glucola. Incidence of adverse events (e.g., nausea, dizziness).
Statistical Analysis:
Pearson's correlation and paired t-tests will assess the agreement between glucose measurements.
ROC analysis will determine the diagnostic performance of the alternative test. Bland-Altman plots will evaluate bias and agreement between the two methods.
Sample Size Calculation:
A minimum of 120 participants is required to detect a clinically significant difference, accounting for attrition.
Recruitment Strategy:
Multicenter Approach: Enrollment from two major hospitals (Bnai Zion and Poria).
Social Media Outreach: Targeted campaigns will inform and recruit participants. Incentives: Participants will receive a complimentary MFM consultation and fetal ultrasound.
Significance:
If grape juice proves to be a viable alternative to the standard GCT, it could improve patient compliance, enhance screening participation, and minimize the discomfort associated with traditional glucose testing.
Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Pregnant individuals scheduled for routine GCT at 24-28 weeks. Well-dated pregnancy (confirmed first-trimester ultrasound). Willingness to comply with study protocol.
Exclusion Criteria:
High-risk individuals requiring direct 100g OGTT (e.g., prior GDM, >40, PCOS).
Intolerance to the alternative drink. Gastrointestinal conditions affecting glucose absorption such as active bowel disiease.
Recent administration for fetal lung maturity after standard GCT.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar). Control Group: Each participant serves as her own control by completing both tests in a randomized order.
Other: Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.
This study investigates a non-carbonated, natural beverage (grape juice) as an alternative glucose-loading method for gestational diabetes screening. Unlike other studies that have explored alternative carbohydrate sources such as jelly beans or gummy candies-which require chewing and may impact dental health-our study focuses on a readily available liquid alternative that closely mimics the glucose absorption kinetics of the standard 50g glucola drink.
Blood glucose concentration after test beverage
Venous plasma glucose ( measured at 60 minutes after each beverage
Time frame: one hour from injestion of the drink
Participant satisfaction with glucose drink
Participant reported satisfaction with the consumed glucose drink, assessed using a 5 point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Time frame: One hour after ingestion of the glucose drink.
Participant preference for glucose challenge test drink
Participant stated preference for the alternative glucose drink compared with the standard glucose challenge test drink, recorded as a categorical variable (alternative drink preferred, standard drink preferred, no preference).
Time frame: One hour after ingestion of the glucose drink.
Adverse events following glucose drink ingestion
Occurrence of self reported adverse events following ingestion of the glucose drink, including nausea and dizziness, recorded as present or absent.
Time frame: One hour after ingestion of the glucose drink.
Gestational age at birth
Gestational age at delivery, measured in completed weeks of gestation, based on best obstetric estimate.
Time frame: At delivery
Neonatal birth weight
Birth weight of the neonate measured in grams immediately after delivery.
Time frame: At birth
Mode of delivery
Mode of delivery categorized as vaginal delivery or cesarean delivery.
Time frame: At delivery
Plan to share: No — De identified individual participant data collected in this study will not be shared outside the study team.
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