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Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sertac ESIN, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier:
NCT01680484
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Nonreassuring Fetal Status
 Dietary Supplement: Bitter chocolate
Dietary Supplement: Orange juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Sami Ulus Children's Hospital:

Primary Outcome Measures:
  • Increase in reactivity of NST [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in the maternal fetal movement perception [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680484

Locations
Turkey
Dr. Sami Ulus Maternity and Children's Training and Research Hospital
Ankara, Turkey, 06080
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Principal Investigator: Sertac Esin, MD Dr. Sami Ulus Maternity and Children's Training and Research Hospital
  More Information

No publications provided

Responsible Party: Sertac ESIN, Principal Investigator, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01680484     History of Changes
Other Study ID Numbers: HEK 10/117-13
Study First Received: September 4, 2012
Last Updated: September 6, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Dr. Sami Ulus Children's Hospital:
non-stress test

Additional relevant MeSH terms:
Fetal Distress
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013