PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome (PREPPeD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Placental Insufficiency
• Intervention / Treatment: Other: Blood sampling

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Meryam Sugulle, PhD, MD; Phone Number: +4722119800; Email: uxsume@ous-hf.no
• Study Contact Backup: Name: Anne Cathrine Staff, PhD, MD; Phone Number: +4722119800; Email: uxnnaf@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Recruiting
    • Oslo University Hospital
    • Contact: Meryam Sugulle, PhD, MD; Phone Number: +4722119800; Email: uxsume@ous-hf.no
    • Contact: Anne Cathrine Staff, PhD, MD; Phone Number: +4722119800; Email: uxnnaf@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Extrastiftelsen; Norwegian SIDS and Stillbirth Society
• Investigators: Principal Investigator: Meryam Sugulle, PhD, MD, Oslo University Hospital, Department of Obstetrics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Preeclampsia; Fetal Growth Restriction; Diabetes in Pregnancy; Reduced Fetal Movements
• Additional Relevant MeSH Terms: Placenta Diseases; Pregnancy Complications; Placental Insufficiency
• Other Study ID Numbers: 36864; 36259 (Other Identifier: Oslo University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No