Fetal DistressCHOCO-NSTNCT07418151
Effect of Maternal Chocolate Consumption on Fetal Non-Stress Test (NST) Reactivity.
A study testing Dark Chocolate and Sugar-free White Chocolate in people with Fetal Distress, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial summary
This is a single-blind, randomized, parallel-group, superiority clinical trial. The study aims to determine whether a single intake of 30g of dark chocolate (≥80% cocoa) by pregnant women with a non-reactive fetal non-stress test (NST) increases the conversion rate to a reactive NST within 20 minutes, compared to… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress
- What is being tested?
- Dark Chocolate and Sugar-free White Chocolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteHonduras
- Study dates
- 15 Feb 2026to 30 Sep 2026
- Phase
- Interventional
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy between 36+0 and 41+6 weeks of gestation.
- Baseline Non-Stress Test (NST) classified as non-reactive after a standard 20-minute recording (absence of ≥2 accelerations of ≥15 beats per minute lasting ≥15 seconds).
- Intact amniotic membranes and not in active labor (cervical dilation <4 cm, with absent or irregular contractions).
- Ability to provide written, informed consent.
- Literacy: Ability to read and write (to ensure comprehension of the consent form and study materials).
- Access to a telephone or electronic device for the 24-hour safety follow-up contact.
Who cannot join
- Pregnancy-related exclusions:
- Multiple gestation (twins, triplets, etc.).
- Known major fetal malformation.
- Diagnosis of severe fetal growth restriction with abnormal umbilical artery Doppler.
- Premature rupture of membranes.
- Active vaginal bleeding or placenta previa with hemorrhage.
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- Suspected or confirmed chorioamnionitis.
- Maternal medical exclusions:
- Severe preeclampsia, eclampsia, or HELLP syndrome.
- Uncontrolled severe hypertension.
- Pregestational diabetes or gestational diabetes requiring insulin or other antihyperglycemic medication.
- Capillary blood glucose level >140 mg/dL at the time of screening.
- Maternal fever ≥38°C or maternal tachycardia >120 beats per minute.
- Interference with test interpretation:
- Use of sympathomimetic drugs within 12 hours prior to the study intervention.
- Maternal cardiac arrhythmias.
- Contraindications to the intervention:
- Known allergy to cocoa or chocolate.
- Severe caffeine intolerance.
- Phenylketonuria.
- Gastrointestinal conditions that would prevent oral intake (e.g., intractable vomiting, ileus, obstruction).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site, 1 recruiting
- Recruiting
Hospital San Felipe
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo A Gutierrez-Ramirez, MD, MSc., 97546940, ricardo.gutierrez@unah.edu.hn
Eliuth Y Martínez López, MD
About this study
Official title: Effect of Maternal Consumption of Dark Chocolate on the Reactivity of the Fetal Non-Stress Test (NST): A Single-Blind, Randomized Clinical Trial.
This is a single-blind, randomized, parallel-group, superiority clinical trial. The study aims to determine whether a single intake of 30g of dark chocolate (≥80% cocoa) by pregnant women with a non-reactive fetal non-stress test (NST) increases the conversion rate to a reactive NST within 20 minutes, compared to observation with a sugar-free white chocolate placebo. A total of 190 singleton pregnant women at 36-41 weeks gestation with a non-reactive NST will be recruited at the Hospital General San Felipe, Tegucigalpa, Honduras. Participants will be randomly assigned to either the intervention group (dark chocolate) or the control group (placebo). The primary outcome is the proportion of NSTs that become reactive. Secondary outcomes include changes in specific cardiotocographic parameters, total monitoring time, need for additional tests, and maternal satisfaction.
Read the detailed description
Background and Rationale:
The fetal non-stress test (NST) is a cornerstone of antepartum fetal surveillance, used to assess fetal well-being by evaluating heart rate accelerations in response to fetal movements. A non-reactive NST, defined by the absence of sufficient accelerations over a 20 to 40-minute period, is a common clinical occurrence. While it can indicate fetal compromise, a significant proportion (up to 50%) are false positives, leading to unnecessary maternal anxiety, prolonged monitoring, costly additional tests (e.g., biophysical profile, contraction stress test), and potentially unwarranted obstetric interventions like induction of labor or cesarean delivery.
Pharmacological agents like methylxanthines (e.g., theophylline) have been used to stimulate fetal activity, but their use is limited by side effects and regulatory considerations. Dark chocolate, rich in theobromine (a methylxanthine) and flavonoids, presents a safe, low-cost, and culturally acceptable alternative. Preliminary studies suggest that maternal consumption of dark chocolate, particularly with high cocoa content (≥70-80%), may stimulate fetal movement and heart rate reactivity, potentially converting a non-reactive NST to a reactive state within minutes. However, existing evidence is heterogeneous, derived from small studies with methodological limitations, and none have been conducted in the Central American population.
This study aims to fill this gap by rigorously evaluating, in a randomized controlled trial setting, whether a single dose of 30g of dark chocolate (≥80% cocoa) is superior to a placebo in converting a non-reactive NST to reactive in pregnant women in Honduras.
Study Objectives:
Primary Objective: To compare the proportion of non-reactive NSTs that convert to reactive within 20 minutes after maternal ingestion of 30g of dark chocolate (≥80% cocoa) versus a placebo control.
Secondary Objectives:
To quantify and compare the change in specific cardiotocographic parameters (number of accelerations, baseline variability) between the groups.
To compare the total time spent in the fetal monitoring unit between the intervention and control groups.
To determine and compare the need for additional fetal surveillance tests or urgent obstetric interventions within 24 hours following the intervention.
To evaluate and compare the incidence of maternal adverse events (e.g., nausea, heartburn, palpitations) within 24 hours.
To assess maternal satisfaction and acceptability of the intervention using a standardized hedonic scale.
- Conditions
- Fetal Distress
- Being tested
- Dark Chocolate, Sugar-free White Chocolate
- Keywords
- Chocolate, Theobromine, Non-Stress Test, Cardiotocography
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark ChocolateDietary supplement
Single oral dose of 30g of dark chocolate (minimum 80% cocoa content). Consumed within 5 minutes after a baseline non-reactive NST.
Sugar-free White ChocolateDietary supplement
Single oral dose of 30g of sugar-free white chocolate, administered similarly. Serves as a placebo control without significant theobromine/caffeine.
| Study group | Role | What they receive |
|---|---|---|
| Dark Chocolate | Experimental | Single oral dose of 30g of dark chocolate (minimum 80% cocoa content). Consumed within 5 minutes after a baseline non-reactive NST. Receives: Dietary Supplement: Dark Chocolate |
| Placebo | Placebo comparator | Single oral dose of 30g of sugar-free white chocolate, administered similarly. Serves as a placebo control without significant theobromine/caffeine. Receives: Dietary Supplement: Sugar-free White Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Non-Stress Tests (NSTs) converting to Reactive status.
NST reactivity is defined per NICHD/ACOG criteria: ≥2 accelerations of ≥15 beats per minute lasting ≥15 seconds over a 20-minute period.
Measured: 20 minutes post-intervention.
Secondary outcomes (6)
Change in number of fetal heart rate accelerations.
The absolute change in the count of fetal heart rate accelerations (defined as ≥15 beats per minute increase lasting ≥15 seconds) from the baseline Non-Stress Test (NST) to the NST performed 20 minutes after the intervention.
Measured: From baseline (0 minutes) to 20 minutes post-intervention.
Change in Fetal Heart Rate Baseline Variability
The change in fetal heart rate baseline variability, measured in milliseconds (ms), from the baseline Non-Stress Test (NST) to the NST performed 20 minutes after the intervention.
Measured: From baseline (0 minutes) to 20 minutes post-intervention.
Total Time in Fetal Monitoring Room
The total duration (in minutes) that the participant remains in the fetal monitoring unit, measured from the start of the baseline Non-Stress Test (NST) until discharge from the monitoring room.
Measured: From start of baseline NST (time 0) until discharge from the monitoring room (assessed up to 60 minutes).
Need for Additional Fetal Surveillance Tests
The proportion of participants in each group for whom the treating obstetrician orders additional fetal surveillance tests (e.g., Biophysical Profile, Contraction Stress Test/Oxytocin Challenge Test) following the intervention.
Measured: Within 24 hours after the intervention.
Incidence of Maternal Adverse Events
The frequency of maternal adverse events (e.g., nausea, heartburn, palpitations, hyperglycemia, allergic reaction) reported or observed within 24 hours following the consumption of the study chocolate or placebo.
Measured: Within 24 hours after the intervention.
Maternal Satisfaction with Intervention
Participant-reported satisfaction with the taste and overall experience of the intervention, measured using a standardized 9-point hedonic scale (1 = "Dislike extremely" to 9 = "Like extremely").
Measured: Immediately after completion of the post-intervention NST (approximately 30 minutes after enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal DistressStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418151
- Sponsor's protocol ID
- PGO-UNAH-49-9-2026
- Acronym
- CHOCO-NST
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Publications
Peek K, Gatherer D, Bennett KJM, Fransen J, Watsford M. Muscle strength characteristics of the hamstrings and quadriceps in players from a high-level youth football (soccer) Academy. Res Sports Med. 2018 Jul-Sep;26(3):276-288. doi: 10.1080/15438627.2018.1447475. Epub 2018 Mar 5.
PubMed 29506423