About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Multiple gestation (twins, triplets, etc.).
Known major fetal malformation.
Diagnosis of severe fetal growth restriction with abnormal umbilical artery Doppler.
Premature rupture of membranes.
Trial design
Treatments tested in this trial
- Dark Chocolate
- Sugar-free White Chocolate