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New treatment option for Fetal Distress
Official title Effect of Maternal Chocolate Consumption on Fetal Non-Stress Test (NST) Reactivity.
ClinicalTrials.gov ID: NCT07418151
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only. Healthy volunteers may be eligible.
You may be able to join 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...
- 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).
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
- 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.
- Interference with test interpretation:
- Use of sympathomimetic drugs within 12 hours prior to the study intervention.
- Maternal cardiac arrhythmias.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Tegucigalpa, Francisco Morazán Department, Honduras
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tegucigalpa, Francisco Morazán Department, Honduras. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.