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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT06857461
Eligibility Criteria:
Inclusion Criteria:
* Postpartum women within 24-48 hours after delivery (vaginal or cesarean).
* Term neonates (37-41 weeks of gestation).
* Exclusive breastfeeding at enrollment.
* Maternal education level of at least primary school completed.
* Ability to use a smartphone with WhatsApp for follow-up support.
Exclusion Criteria:
* Maternal conditions that may affect breastfeeding, such as flat or inverted nipples, diabetes, hypertension, or morbid obesity.
* Maternal medication with effects on lactation.
* Cigarette smoking.
* Neonatal conditions impacting breastfeeding, including congenital heart defects, cleft lip/palate, or ankyloglossia.
* Use of infant formula, pacifiers, or bottles before enrollment.
* Diagnosed maternal or neonatal illness after study enrollment that may interfere with breastfeeding.
* Newborns who experienced hypoglycemia, weight loss equal to or greater than 7%, or any condition related to breastfeeding failure during their hospital stay.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06857461
Study Brief:
Protocol Section:
NCT06857461