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Clinical Trials/NCT01680484
NCT01680484CompletedNot Applicable

Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study

Dr. Sami Ulus Children's Hospital2 sites in 1 country180 target enrollmentStarted: February 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
180
Locations
2
Primary Endpoint
Increase in reactivity of NST

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Increase in reactivity of NST

Time Frame: 30 minutes

Secondary Outcomes

  • Increase in the maternal fetal movement perception(30 minutes)

Investigators

Sponsor
Dr. Sami Ulus Children's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sertac ESIN

Principal Investigator

Dr. Sami Ulus Children's Hospital

Study Sites (2)

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