The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Complications
- Sponsor
- Oslo University Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Newborn asphyxia
- Last Updated
- 5 years ago
Overview
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.
Investigators
Meryam Sugulle
Consultant Obstetrician
Oslo University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Newborn asphyxia
Time Frame: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
Combination of outcomes 1 and 2
Fetal acidaemia
Time Frame: 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
Time Frame: 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
Meconium aspiration syndrome
Time Frame: Diagnosis within 28 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
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
Neonatal hypoxic-ischemic encephalopathy
Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Therapeutic hypothermia of the neonate
Time Frame: Within 3 days postpartum; data assessed throughout study period of 140 months
Secondary Outcomes
- Pathological placenta histology findings(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)
- Abnormal intrapartum CTG patterns(Intrapartum CTG; data assessed throughout study period of 140 months)