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

Nonreassuring Fetal Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680484
• Other study ID #: HEK 10/117-13
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: September 6, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Dr. Sami Ulus Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Fetal Distress
• Nonreassuring Fetal Status

Intervention

Dietary Supplement:
• Bitter chocolate

• Orange juice

Locations

Country	Name	City	State
Turkey	Dr. Sami Ulus Maternity and Children's Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in reactivity of NST		30 minutes	No
Secondary	Increase in the maternal fetal movement perception		30 minutes	No