Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
NCT07418151

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

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

190

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy between 36+0 and 41+6 weeks of gestation
  • Baseline Non-Stress Test (NST) 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
Not Eligible

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 other antihyperglycemic medication
  • Capillary blood glucose level over 140 mg/dL at screening
  • Maternal fever of 38°C or higher or maternal tachycardia over 120 beats per minute
  • Use of sympathomimetic drugs within 12 hours prior to intervention
  • Maternal cardiac arrhythmias
  • Known allergy to cocoa or chocolate
  • Severe caffeine intolerance
  • Phenylketonuria
  • Gastrointestinal conditions preventing oral intake (e.g., intractable vomiting, ileus, obstruction)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital San Felipe

Tegucigalpa, Francisco Morazán Department, Honduras, 11101

Actively Recruiting

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Research Team

R

Ricardo A Gutierrez-Ramirez, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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