PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Complications, Placental Insufficiency

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I. Post Dates<br>Pregnant women referred for clinical post term evaluation and/or labour induction. Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|
| II. Induction of Labour<br>Pregnant women ≥37+0 GW (gestational week) referred for labour induction (any cause). Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|
| III. All Outpatients<br>Pregnant women ≥37+0 GW presenting for any medical reason at OUH outpatient clinic. Blood sampling | Other: Blood sampling<br>* Maternal blood sampling<br>|
| IV. Diabetes in Pregnancy<br>Pregnant women ≥36+0 GW with pregestational or gestational diabetes. Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|
| V. Reduced Fetal Movements<br>Pregnant women ≥37+0 GW with reduced fetal movements and/or referred due to reduced symphysis-fundal height. Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|
| VI. Hypertensive Disorders in Pregnancy<br>Pregnant women referred for preeclampsia (or other pregnancy induced hypertensive disorders) and/or suspected fetal growth restriction; longitudinal cohorts. Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|
| VII. All Labour Admissions<br>All pregnant women ≥37+0 GW admitted for labour. Blood sampling. | Other: Blood sampling<br>* Maternal blood sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal 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.) | 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 | 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 | 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 |  | 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 | 
| 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 | 
| Rate of acute cesarean section (due to suspected fetal distress) |  | Data assessed throughout study period of 140 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) |  | Data assessed throughout study period of 140 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Diabetes in Pregnancy, Fetal Growth Restriction, Reduced Fetal Movements