What is dark chocolate studying for fetal distress?

This trial is studying whether eating 30g of dark chocolate with at least 80% cocoa can change a non-reactive fetal non-stress test (NST) to reactive within 20 minutes in pregnant women. It aims to find a safe, simple way to improve fetal monitoring results and reduce unnecessary stress. The study is sponsored by Universidad Nacional Autonoma de Honduras.

Who may be eligible for this fetal distress clinical trial?

Women aged 18 to 49 years who are pregnant with a single baby between 36 and 41 weeks gestation may be eligible. They must have a recent non-reactive fetal NST and be able to provide informed consent. Women with multiple pregnancies or certain pregnancy complications are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this fetal distress clinical trial?

Study-related care, including the study chocolate and all trial visits, is provided at no cost. However, personal travel costs may vary and are not guaranteed to be covered. Participants should plan accordingly for their visit expenses.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 49Years

FEMALE

Healthy Volunteers

ID07418151

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

Led by Universidad Nacional Autonoma de Honduras · Updated on 2026-03-03

190

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a single intake of 30g of dark chocolate with at least 80 cocoa can improve the reactivity of the fetal non-stress test NST in pregnant women who currently have a non-reactive NST. This single-blind, randomized clinical trial focuses on pregnant women between 36 and 41 weeks gestation with singleton pregnancies. The goal is to see if dark chocolate can increase the rate of NSTs becoming reactive within 20 minutes compared to a sugar-free white chocolate placebo. This study also examines related heart rate patterns and maternal satisfaction. Participants will be randomly assigned to one of two groups one group will consume a single oral dose of 30g dark chocolate within 5 minutes after a baseline non-reactive NST, while the control group will receive a single oral dose of 30g sugar-free white chocolate as a placebo. The study tracks changes in fetal heart activity and time spent in monitoring, along with any maternal side effects. The trial is designed to assess the superiority of dark chocolate over placebo in converting NST status. During the study, participants will undergo a baseline NST followed by treatment intake and monitoring for up to 60 minutes. Researchers will measure the proportion of NSTs that become reactive within 20 minutes, changes in fetal heart rate accelerations and variability, total monitoring time, and the need for further fetal tests or urgent obstetric interventions within 24 hours. Maternal satisfaction and any adverse events will be evaluated shortly after intervention. Participants will be followed up by telephone or electronic device for safety within 24 hours. The trial is planned to last until September 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 49Years

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Singleton pregnancy between 36+0 and 41+6 weeks of gestation
Baseline Non-Stress Test classified as non-reactive after a 20-minute recording
Intact amniotic membranes and not in active labor (cervical dilation less than 4 cm, absent or irregular contractions)
Ability to provide written, informed consent
Ability to read and write
Access to a telephone or electronic device for 24-hour safety follow-up contact

You will not qualify if you...

Multiple gestation (twins, triplets, etc.)
Known major fetal malformation
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
Severe preeclampsia, eclampsia, or HELLP syndrome
Uncontrolled severe hypertension
Pregestational diabetes or gestational diabetes requiring insulin or antihyperglycemic medication
Capillary blood glucose level above 140 mg/dL at screening
Maternal fever 38°C or higher or maternal tachycardia over 120 beats per minute
Use of sympathomimetic drugs within 12 hours before intervention
Maternal cardiac arrhythmias
Known allergy to cocoa or chocolate
Severe caffeine intolerance
Phenylketonuria
Gastrointestinal conditions preventing oral intake (e.g., vomiting, ileus, obstruction)

Research Team

Ricardo A Gutierrez-Ramirez, MD, MSc

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