Placental Insufficiency, Pregnancy Complications
Conditions
Keywords
Preeclampsia, Diabetes in Pregnancy, Fetal Growth Restriction, Reduced Fetal Movements
Brief summary
The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.
Detailed description
The main aim of the PREPPeD study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.
Interventions
OTHERBlood sampling
Maternal blood sampling
Sponsors
Norwegian SIDS and Stillbirth Society
Extrastiftelsen
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* All pregnant women scheduled to deliver at the Department of Obstetrics at OUH who qualify for the study groups as specified in the Groups and Intervention section.
Exclusion criteria
* Women who do not understand Norwegian or English * Communicable disease * Younger than 18 years of age * Legally incompetent * Fetal malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute cesarean section (due to suspected fetal distress) | Data assessed throughout study period of 140 months | — |
| Meconium aspiration syndrome | Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months | — |
| Neonatal hypoxic-ischemic encephalopathy | Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months | — |
| Therapeutic hypothermia of the neonate | Within 3 days postpartum; data assessed throughout study period of 140 months | — |
| Fetal acidaemia | Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months | In neonates delivered by cesarean section (CS) without labour (defined as absence of regular uterine contractions): Umbilical artery blood (transporting blood from the fetus to the placenta) pH\<7.13 and arterial BD \>10.0 In neonates from labored delivery (regardless of subsequent delivery method, vaginal or CS): Umbilical artery blood pH\<7.05 and arterial BD\>14; OR Umbilical artery blood (or venous if arterial blood not available) lactate above Reference level for respective gestational age according to publication by Wiberg N et al ,BJOG 2008 (doi: 10.1111/j.1471-0528.2008.01707.x.) |
| Newborn low Apgar score | Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months | \<4 at 1 minute OR \<7 at 5 minutes |
| Newborn asphyxia | Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months | Combination of outcomes 1 and 2 |
| Rate of intrauterine fetal demise/intra-/postpartum fetal death | Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months | — |
| Neonatal intubation/mechanical ventilation>6 hours | Within 28 days postpartum; data assessed throughout study period of 140 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological placenta histology findings | Data assessed throughout study period of 140 months |
| Abnormal intrapartum CTG patterns | Intrapartum CTG; data assessed throughout study period of 140 months |
| Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) | Data assessed throughout study period of 140 months |
Countries
Norway
Contacts
Primary ContactMeryam Sugulle, PhD, MD
Backup ContactAnne Cathrine Staff, PhD, MD
Outcome results
None listed