Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns
Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
1 other identifier
interventional
180
1 country
1
Brief Summary
There are multiple factors affecting the variability and acceleration pattern of fetal heart rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be stimulated by manual manipulation, sound, light, change in maternal position and maternal ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently practiced in outpatient settings. This is not only medical but also a social routine. In this study the investigators have chosen the two most popular so-called 'fetal accelerators', chocolate and orange juice against no intervention and tried to find any usefulness of these on non-reactive NST patterns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedSeptember 7, 2012
September 1, 2012
10 months
September 4, 2012
September 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in reactivity of NST
30 minutes
Secondary Outcomes (1)
Increase in the maternal fetal movement perception
30 minutes
Study Arms (3)
Bitter chocolate
ACTIVE COMPARATOR50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey
Orange juice
ACTIVE COMPARATORÜlker İçim Orange Juice 250 cc, İstanbul, Turkey
Control
NO INTERVENTIONSit and rest
Interventions
Eligibility Criteria
You may qualify if:
- singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.
You may not qualify if:
- multiple pregnancies, fetal anomaly, hypertension, intrauterine growth restriction, active labor, contractions or decelerations on NST, absence of a first or second trimester ultrasonography for accurate gestational dating, pre-gestational or gestational diabetes and known allergy to chocolate or orange
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Sami Ulus Maternity and Children's Training and Research Hospital
Ankara, 06080, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sertac Esin, MD
Dr. Sami Ulus Maternity and Children's Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
February 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
September 7, 2012
Record last verified: 2012-09