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.
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.
Multiple gestation (twins, triplets, etc.).
Known major fetal malformation.
Diagnosis of severe fetal growth restriction with abnormal umbilical artery Doppler.
Premature rupture of membranes.
Parallel
Dark Chocolate
Dietary supplementSingle oral dose of 30g of dark chocolate (minimum 80% cocoa content). Consumed within 5 minutes after a baseline non-reactive NST.
Sugar-free White Chocolate
Dietary supplementSingle oral dose of 30g of sugar-free white chocolate, administered similarly. Serves as a placebo control without significant theobromine/caffeine.
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.
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.
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.
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.
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.
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