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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital San Felipe
  Tegucigalpa, Francisco Morazán Department, Honduras Recruiting

Study contacts

• Study coordinator: Ricardo A Gutierrez-Ramirez, MD, MSc
• Email: ricardo.gutierrez@unah.edu.hn
• Phone: +50497546940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.