Clinical trial NCT03100084: PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome
Official title: The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Complications
Placental Insufficiency
Keywords: Preeclampsia
Diabetes in Pregnancy
Fetal Growth Restriction
Reduced Fetal Movements
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian SIDS and Stillbirth Society
name: Extrastiftelsen
First posted: 2017-04-04
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Fetal acidaemia
timeFrame: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
measure: Newborn low Apgar score
timeFrame: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
measure: Newborn asphyxia
timeFrame: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
measure: Rate of intrauterine fetal demise/intra-/postpartum fetal death
timeFrame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
measure: Neonatal intubation/mechanical ventilation>6 hours
timeFrame: Within 28 days postpartum; data assessed throughout study period of 140 months
measure: Meconium aspiration syndrome
timeFrame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
measure: Neonatal hypoxic-ischemic encephalopathy
timeFrame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
measure: Therapeutic hypothermia of the neonate
timeFrame: Within 3 days postpartum; data assessed throughout study period of 140 months
measure: Rate of acute cesarean section (due to suspected fetal distress)
timeFrame: Data assessed throughout study period of 140 months
Secondary outcomes:
measure: Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)
timeFrame: Data assessed throughout study period of 140 months
measure: Pathological placenta histology findings
timeFrame: Data assessed throughout study period of 140 months
measure: Abnormal intrapartum CTG patterns
timeFrame: Intrapartum CTG; data assessed throughout study period of 140 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Department of Obstetrics
name: Meryam Sugulle, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitlid-Mork B, Turowski G, Bowe S, Staff AC, Sugulle M. Circulating angiogenic profiles and histo-morphological placental characteristics of uncomplicated post-date pregnancies. Placenta. 2021 Jun;109:55-63. doi: 10.1016/j.placenta.2021.04.017. Epub 2021 May 5.