Placental development and function. Placental development and function.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the Predict Studie (MEC-2004-227), a subject must meet all of the following criteria:18 years of age or older.Competent.Pregnancy <10 weeks (so that at least 2 of the 3 ultrasound examinations can take place in the first trimester).Pregnancy up to 12 weeks (so that at least one ultrasound scan can take place in the first trimester, in week 11). This only applies to pGZ participants. Inclusion can be combined with participation in the virtual embryoscope, cell-free DNA, or PROMOTE sub-studies.Willing to sign the consent form.Women who come to the outpatient clinic for medical preconception counseling and/or preconception counseling focused on nutrition and lifestyle (Polikliniek Gezond Zwanger (PGZ)) orWomen who come to one of the outpatient clinics of the Obstetrics & Gynecology department for a pregnancy check-up or prenatal diagnostics orWomen who are admitted with suspected fetal growth restriction and/or preeclampsia, congenital abnormalities and/or premature birth and/or twin pregnancy, orWomen who give birth or have given birth at Erasmus MC / Sophia Birth Center.In order to be eligible to participate in the PEPPER Studie, a subject must meet all of the following criteria:Scheduled cesarean section.Singleton pregnancy.For the current study:Scheduled cesarean section.Singleton pregnancy.> 37 weeks of pregnancy.
Exclusion criteria
Exclusion criteria: There are no exclusion criteria specified in the protocol of the Predict studie.A potential subject who meets any of the following criteria will be excluded from participation in the PEPPER study: Twin pregnancy.Diabetes mellitus / gravidarum.Hypertension.Fetal congenital abnormalities.Macrosomia (fetal BW >p90).FGR (fetal BW <p10)Infection disease (eg. HIV, Hepatitis B, Zika, COVID-19 during last trimester of pregnancy).A potential subject who meets any of the following criteria will be excluded from participation in this study: <18 years of age at time of inclusion.Inability to give informed consent.Twin pregnancy.Diabetes mellitus / gravidarum.Hypertension.Fetal congenital abnormalities.Macrosomia (fetal BW >p90).FGR (fetal BW <p10).IUVD.SGA.Infection disease (eg. HIV, Hepatitis B, Zika, COVID-19 during last trimester of pregnancy).Cannabis use (controls).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maturation (MAT) maternal vascular malperfusion (MVM) Hemorrhage/abruption (MVM1) Infarction (MVM2) Distal villous hypoplasia (MVM3)Ischemia (MVM4) Decidual arteriopathy (MVM5) Decidual necrosis (MVM6) fetal vascular malperfusion (FVM) thrombosis (FVM1) avascular villi (FVM1) thrombi (FVM1) asscending intraunterine infection (AIUI)chorioamnionitis (AIUI1) stage (AIUI2) infiltrate (AIUI3) fetal response/funisitis (AIUI4) AIUI4 umbilical vein AIUI4 umbilical arteries AIUI4 chronic vessels villitis of unknown etiology (VUE) grade (VUE1) Resolved villitis (VUE2) Perivillous fibrin/destruction trophoblast (VUE3) perivillous fibrinoid desposition (MPVFD) chronic histiocytic intervillositis (CHIV) Chronic deciduitis (CD) Chrorangiosis/Chorangiomatosis (CH) Intervillous fibrin (IV) Fetal hypoxia (FH)All outcomes are categorical (present/absent or normal/moderated/accelerated). To interpret these findings, we aim to compare this group to a control group of healthy placentas from the PREDICT study, which has a large pool of placental histopathology data from uncomplicated pregnancies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam