Nonreassuring Fetal StatusNCT01680484
Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns
A study testing Bitter chocolate and Orange juice in people with Nonreassuring Fetal Status, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nonreassuring Fetal Status
- What is being tested?
- Bitter chocolate and Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sami Ulus Maternity and Children's Training and Research Hospital
Ankara, 06080
About this study
Official title: Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
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.
- Conditions
- Nonreassuring Fetal Status
- Being tested
- Bitter chocolate, Orange juice
- Keywords
- non-stress test
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bitter chocolateDietary supplement
Orange juiceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Bitter chocolate | Active comparator | 50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey Receives: Dietary Supplement: Bitter chocolate |
| Orange juice | Active comparator | Ülker İçim Orange Juice 250 cc, İstanbul, Turkey Receives: Dietary Supplement: Orange juice |
| Control | No intervention | Sit and rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in reactivity of NST
Measured: 30 minutes
Secondary outcomes (1)
Increase in the maternal fetal movement perception
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonreassuring Fetal StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sertac ESIN, Dr. Sami Ulus Children's Hospital
- Investigators
- Sertac Esin, MD, Principal investigator, Dr. Sami Ulus Maternity and Children's Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680484
- Sponsor's protocol ID
- HEK 10/117-13
- Status last verified
- Sep 2012
- First submitted
- 4 Sep 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT01680484
- Acronym / sponsor ID
- HEK 10/117-13
- Conditions
- Nonreassuring Fetal Status
- Keywords
- non-stress test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bitter chocolate | Active comparator | Dietary Supplement: Bitter chocolate50 grams Ülker Golden %70 bitter chocolate, İstanbul, Turkey |
| Orange juice | Active comparator | Dietary Supplement: Orange juiceÜlker İçim Orange Juice 250 cc, İstanbul, Turkey |
| Control | No intervention | –Sit and rest |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bitter chocolate | Dietary supplement | Bitter chocolate |
| Orange juice | Dietary supplement | Orange juice |
Primary outcome
Increase in reactivity of NST
Time frame: 30 minutes
1 secondary outcome
Increase in the maternal fetal movement perception
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sertac Esin, MD principal investigator
Dr. Sami Ulus Maternity and Children's Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bitter chocolate and Orange juice in people with Nonreassuring Fetal Status, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in reactivity of NST (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.