Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07418151
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT07418151
Study Brief:
Protocol Section:
NCT07418151