NCT07418151

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 10, 2026

Last Update Submit

February 27, 2026

Conditions

Fetal Distress

Keywords

ChocolateTheobromineNon-Stress TestCardiotocography

Outcome Measures

Primary Outcomes (1)

  • Proportion of Non-Stress Tests (NSTs) converting to Reactive status.

    NST reactivity is defined per NICHD/ACOG criteria: ≥2 accelerations of ≥15 beats per minute lasting ≥15 seconds over a 20-minute period.

    20 minutes post-intervention.

Secondary Outcomes (6)

  • Change in number of fetal heart rate accelerations.

    From baseline (0 minutes) to 20 minutes post-intervention.

  • Change in Fetal Heart Rate Baseline Variability

    From baseline (0 minutes) to 20 minutes post-intervention.

  • Total Time in Fetal Monitoring Room

    From start of baseline NST (time 0) until discharge from the monitoring room (assessed up to 60 minutes).

  • Need for Additional Fetal Surveillance Tests

    Within 24 hours after the intervention.

  • Incidence of Maternal Adverse Events

    Within 24 hours after the intervention.

  • +1 more secondary outcomes

Study Arms (2)

Dark Chocolate

EXPERIMENTAL

Single oral dose of 30g of dark chocolate (minimum 80% cocoa content). Consumed within 5 minutes after a baseline non-reactive NST.

Dietary Supplement: Dark Chocolate

Placebo

PLACEBO COMPARATOR

Single oral dose of 30g of sugar-free white chocolate, administered similarly. Serves as a placebo control without significant theobromine/caffeine.

Dietary Supplement: Sugar-free White Chocolate

Interventions

Dark ChocolateDIETARY_SUPPLEMENT

Single oral dose of 30g of dark chocolate (minimum 80% cocoa content). Consumed within 5 minutes after a baseline non-reactive NST.

Dark Chocolate
Sugar-free White ChocolateDIETARY_SUPPLEMENT

Single oral dose of 30g of sugar-free white chocolate, administered similarly. Serves as a placebo control without significant theobromine/caffeine.

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • Interference with test interpretation:
  • Use of sympathomimetic drugs within 12 hours prior to the study intervention.
  • Maternal cardiac arrhythmias.
  • Contraindications to the intervention:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Felipe

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Related Publications (1)

  • Peek K, Gatherer D, Bennett KJM, Fransen J, Watsford M. Muscle strength characteristics of the hamstrings and quadriceps in players from a high-level youth football (soccer) Academy. Res Sports Med. 2018 Jul-Sep;26(3):276-288. doi: 10.1080/15438627.2018.1447475. Epub 2018 Mar 5.

    PMID: 29506423BACKGROUND

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ricardo A Gutierrez-Ramirez, MD, MSc

CONTACT

+50497546940ricardo.gutierrez@unah.edu.hn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking: Single (Outcomes Assessor) Who is masked: The obstetrician analyzing the cardiotocographic tracings (outcome assessor) will be blinded to group assignment. Participants and clinical staff administering the intervention will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

all IPD collected throughout the trial

Shared Documents
CSR
Time Frame
Beginning 3 months and ending 5 years after the publication of results

Locations

HO(1)