Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
| Registry | NCT01680484 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single |
| Enrollment | 180 (Actual) |
| Sponsor | Dr. Sami Ulus Children's Hospital (Other) |
| Conditions | Nonreassuring Fetal Status |
| Interventions | Bitter chocolate, Orange juice (Dietary supplement) |
| Dates | start 2011-02-01, primary completion 2011-12-01, completion 2012-01-01, first posted 2012-09-07, last updated 2012-09-07 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bitter chocolate | Active comparator | Dietary Supplement: Bitter chocolate | 50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey |
| Orange juice | Active comparator | Dietary Supplement: Orange juice | Ülker İçim Orange Juice 250 cc, İstanbul, Turkey |
| Control | No intervention | Sit and rest |
Sex: Female, ages: 18 Years to 45 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dr. Sami Ulus Maternity and Children's Training and Research Hospital | Ankara | Turkey (Türkiye) |