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Completed

NCT Number: NCT01680484

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

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.

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Key information

Conditions

Nonreassuring Fetal Status Fetal Distress Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sami Ulus Maternity and Children's Training and Research Hospital

Ankara, 06080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bitter chocolate

Dietary Supplement

Orange Juice

Dietary Supplement

Primary outcomes

  1. Increase in reactivity of NST

    Time frame: 30 minutes

Secondary outcomes

  1. Increase in the maternal fetal movement perception

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 7, 2012
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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