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

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 Overview

• Status: Completed
• Conditions: Nonreassuring Fetal Status
• Intervention / Treatment: Dietary supplement: Bitter chocolate; Dietary supplement: Orange juice

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06080
    • Dr. Sami Ulus Maternity and Children's Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bitter chocolate; 50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey	Dietary supplement: Bitter chocolate
ACTIVE_COMPARATOR: Orange juice; Ülker İçim Orange Juice 250 cc, İstanbul, Turkey	Dietary supplement: Orange juice
NO_INTERVENTION: Control; Sit and rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in reactivity of NST	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Increase in the maternal fetal movement perception	30 minutes

Collaborators and Investigators

• Sponsor: Dr. Sami Ulus Children's Hospital
• Investigators: Principal Investigator: Sertac Esin, MD, Dr. Sami Ulus Maternity and Children's Training and Research Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (ESTIMATE): September 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: non-stress test
• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: HEK 10/117-13