Clinical Trial: PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"

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 Summary: 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.
Sponsor: Oslo University Hospital

Current Primary Outcome:

  • 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 lactate>3.9 mmol/L (or umbilical vein lactate >3.4 mmol/L if umbilical artery blood sample not available

  • 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
  • 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
  • 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 peri

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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 ]


    Original Secondary Outcome: Same as current

    Information By: Oslo University Hospital

    Dates:
    Date Received: March 21, 2017
    Date Started: September 15, 2016
    Date Completion: September 1, 2022
    Last Updated: March 28, 2017
    Last Verified: March 2017