PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome (PREPPeD)

December 17, 2020 updated by: Meryam Sugulle, Oslo University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Contact:
          • Anne Cathrine Staff, PhD, MD
          • Phone Number: +4722119800
          • Email: uxnnaf@ous-hf.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 (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
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
Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
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
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
Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
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 period of 140 months
Within 28 days postpartum; data assessed throughout study period of 140 months
Meconium aspiration syndrome
Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal hypoxic-ischemic encephalopathy
Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Therapeutic hypothermia of the neonate
Time Frame: Within 3 days postpartum; data assessed throughout study period of 140 months
Within 3 days postpartum; data assessed throughout study period of 140 months
Rate of acute cesarean section (due to suspected fetal distress)
Time Frame: Data assessed throughout study period of 140 months
Data assessed throughout study period of 140 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)
Time Frame: Data assessed throughout study period of 140 months
Data assessed throughout study period of 140 months
Pathological placenta histology findings
Time Frame: Data assessed throughout study period of 140 months
Data assessed throughout study period of 140 months
Abnormal intrapartum CTG patterns
Time Frame: Intrapartum CTG; data assessed throughout study period of 140 months
Intrapartum CTG; data assessed throughout study period of 140 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Extrastiftelsen
Norwegian SIDS and Stillbirth Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meryam Sugulle, PhD, MD, Oslo University Hospital, Department of Obstetrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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