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

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ClinicalTrials.gov Identifier: NCT01680484
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):
Sertac ESIN, Dr. Sami Ulus Children's Hospital

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.

Condition or disease Intervention/treatment
Nonreassuring Fetal Status Dietary Supplement: Bitter chocolate Dietary Supplement: Orange juice

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
Study Start Date : February 2011
Primary Completion Date : December 2011
Study Completion Date : January 2012

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



Primary Outcome Measures :
  1. Increase in reactivity of NST [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Increase in the maternal fetal movement perception [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Fetal Distress
Signs and Symptoms