Dark chocolate to prompt a non-reactive fetal NST to become reactive

Effect of Maternal Consumption of Dark Chocolate on the Reactivity of the Fetal Non-Stress Test (NST): A Single-Blind, Randomized Clinical Trial.

This will test whether one 30 g serving of dark chocolate (≥80% cocoa) given to pregnant women at 36–41 weeks with a non-reactive NST helps the fetal heart-rate tracing become reactive within 20 minutes compared with a sugar-free white chocolate placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: Universidad Nacional Autonoma de Honduras (Academic / other)
• Locations: 1 site (Tegucigalpa, Francisco Morazán Department)
• Trial ID: NCT07418151 on ClinicalTrials.gov

What this trial studies

This single-blind, randomized, parallel-group superiority trial will enroll 190 singleton pregnancies at 36+0 to 41+6 weeks with a non-reactive non-stress test at Hospital San Felipe in Tegucigalpa, Honduras. Participants will be randomized to receive either 30 g of dark chocolate (≥80% cocoa) or a sugar-free white chocolate placebo and monitored by cardiotocography for conversion to a reactive NST within 20 minutes. 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. The trial excludes multiple gestations, major fetal malformations, ruptured membranes, active hemorrhage, suspected chorioamnionitis, severe fetal growth restriction with abnormal Dopplers, and women in active labor.

Who should consider this trial

Good fit: Ideal candidates are singleton pregnant women between 36+0 and 41+6 weeks with an intact pregnancy and a standard 20-minute non-reactive NST who are not in active labor and can provide informed consent.

Not a fit: Patients with multiple gestation, known major fetal anomalies, ruptured membranes, active significant vaginal bleeding or placenta previa with hemorrhage, suspected chorioamnionitis, severe growth restriction with abnormal Dopplers, or those in active labor are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, this could provide a quick, low-cost, noninvasive way to reduce prolonged monitoring, additional testing, and unnecessary obstetric interventions for many non-reactive NSTs.

How similar studies have performed: Small, heterogeneous prior studies have suggested maternal dark chocolate can stimulate fetal movement and NST reactivity, but the evidence is limited, mixed, and not definitive.

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).

Where this trial is running

Tegucigalpa, Francisco Morazán Department

• Hospital San Felipe — Tegucigalpa, Francisco Morazán Department, Honduras (Recruiting)

Study contacts

• Study coordinator: Ricardo A Gutierrez-Ramirez, MD, MSc

Conditions Fetal Distress; Chocolate; Theobromine; Non-Stress Test; Cardiotocography