NCT07418151 Effect of Maternal Chocolate Consumption on Fetal Non-Stress Test (NST) Reactivity.

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This trial targets 190 participants in total. It began in 2026-02-15 with a primary completion date of 2026-08-31.

Brief 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 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

Inclusion Criteria: * 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. Exclusion Criteria: 1. 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. * Suspected or confirmed chorioamnionitis. 2. 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. 3. Interference with test interpretation: * Use of sympathomimetic drugs within 12 hours prior to the study intervention. * Maternal cardiac arrhythmias. 4. 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).

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