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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT02756169
Eligibility Criteria:
Inclusion Criteria:
* Pregnant Women \<18 years old with a BMI \>=28, and women \<18 years old with a BMI \>=27, utilizing their pre-pregnancy weight.
* Pregnant women within the second or early third trimester (week 20 through week 34 of gestation).
Exclusion Criteria:
* Pregnant women under 15 years old.
* Pregnant women diagnosed with HIV or AIDS, Hepatitis B and C, or the Human T lymphotropic virus. In the presence of these, women have the contraindication to feed their children with breast milk.
* Pregnant women with medical conditions that could interfere with breastfeeding, as severe infections transmitted through breast milk.
* Pregnant women with previous breast surgery (as breast reduction) because the lactiferous ducts end up damaged and may lead to poor or no milk production at all.
* Pregnant women that are taking medications that prevent carrying out breastfeeding.
* Pregnant women with a multiple pregnancy (in case of twins, the first born should be taken for the study).
Exit criteria:
* Newborns with less than 35 weeks of gestational age.
* Newborns dispatched to the neonatal intensive care unit (NICU) from the first day of life.
* Newborns who present major congenital malformations, severe enough to prevent the breastfeeding.
Elimination criteria:
* Newborns with hypertrophy (large for gestational age), because they may present hypoglycemia and therefore some should require to remain in fast even after starting oral feeding and especially on the first day of life.
* Newborns that enter to the Intermediate Care Unit for a neonatal or maternal adverse event even if the breastfeeding was already initiated.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Study:
NCT02756169
Study Brief:
Protocol Section:
NCT02756169