Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (Placent… (NCT02211651) | Clinical Trial Compass
CompletedNot Applicable
Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
United States3 participantsStarted 2013-12
Plain-language summary
The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Quantity of Blood Vessels and Capillaries
Timeframe: Visit 3, at 39 weeks
2
Quantity of macrophages
Timeframe: Visit 3 at 39 weeks + 1 day
Trial details
NCT IDNCT02211651
SponsorAdventHealth Translational Research Institute