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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Maternal blood sampling
Oslo University Hospital
Oslo, Norway
RECRUITINGFetal acidaemia
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.)
Time frame: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
Newborn low Apgar score
\<4 at 1 minute OR \<7 at 5 minutes
Time frame: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
Newborn asphyxia
Combination of outcomes 1 and 2
Time frame: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
Rate of intrauterine fetal demise/intra-/postpartum fetal death
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal intubation/mechanical ventilation>6 hours
Time frame: Within 28 days postpartum; data assessed throughout study period of 140 months
Meconium aspiration syndrome
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal hypoxic-ischemic encephalopathy
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
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Therapeutic hypothermia of the neonate
Time frame: Within 3 days postpartum; data assessed throughout study period of 140 months
Rate of acute cesarean section (due to suspected fetal distress)
Time frame: Data assessed throughout study period of 140 months
Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)
Time frame: Data assessed throughout study period of 140 months
Pathological placenta histology findings
Time frame: Data assessed throughout study period of 140 months
Abnormal intrapartum CTG patterns
Time frame: Intrapartum CTG; data assessed throughout study period of 140 months