PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

• Conditions: Pregnancy Complications; Placental Insufficiency
• Interventions: Other: Blood sampling

• Registration Number: NCT03100084
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2016-09-15
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Therapeutic hypothermia of the neonate	Within 3 days postpartum; data assessed throughout study period of 140 months
Newborn asphyxia	Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months	Combination of outcomes 1 and 2
Neonatal hypoxic-ischemic encephalopathy	Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Fetal acidaemia	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	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	Diagnosis within 28 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
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

Secondary Outcome Measures

Name	Time	Method
Abnormal intrapartum CTG patterns	Intrapartum CTG; data assessed throughout study period of 140 months
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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway