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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02211651
Eligibility Criteria:
Pregnant women Inclusion Criteria:
* Pregnant women undergoing planned cesarean section at 39 weeks of gestation due to: a) elective cesarean section; b) breach presentation c) repeat cesarean section (the rationale for choosing these women is to select only women that have no other risk factors or complications during pregnancy that might affect the outcome)
* Age between 18 and 40 years old
* Pre-pregnancy BMI between 20 and 25 kg/m2 (lean) and \>30 kg/m2 (obese)
* Singleton pregnancies
* Allowing their neonates to participate in the trial
Pregnant women Exclusion Criteria:
* Taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain.
* Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
* Pre-eclampsia, eclampsia during this pregnancy
* Liver, kidney, thyroid disease, cancer
* Smoking or using illegal drugs or alcohol during this pregnancy
* Fetal umbilical blood and/or placenta are collected for another reason, i.e. parents decide on cord blood storage
Neonate Inclusion criteria:
\- Live neonates born to the study participating mothers
Neonate exclusion criteria:
\- Neonate distress as to require admission to the Neonatal Intensive Care Unit.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02211651
Study Brief:
Protocol Section:
NCT02211651