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PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

NCT ID: NCT03100084

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-15

Study Completion Date

2022-09-01

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.

Conditions

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Pregnancy Complications Placental Insufficiency

Keywords

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Preeclampsia Diabetes in Pregnancy Fetal Growth Restriction Reduced Fetal Movements

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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I. Post Dates

Pregnant women referred for clinical post term evaluation and/or labour induction.

Blood sampling.

Blood sampling

Intervention Type OTHER

Maternal blood sampling

II. Induction of Labour

Pregnant women ≥37+0 GW (gestational week) referred for labour induction (any cause).

Blood sampling.

Blood sampling

Intervention Type OTHER

Maternal blood sampling

III. All Outpatients

Pregnant women ≥37+0 GW presenting for any medical reason at OUH outpatient clinic.

Blood sampling

Blood sampling

Intervention Type OTHER

Maternal blood sampling

IV. Diabetes in Pregnancy

Pregnant women ≥36+0 GW with pregestational or gestational diabetes. Blood sampling.

Blood sampling

Intervention Type OTHER

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.

Blood sampling

Intervention Type OTHER

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.

Blood sampling

Intervention Type OTHER

Maternal blood sampling

VII. All Labour Admissions

All pregnant women ≥37+0 GW admitted for labour. Blood sampling.

Blood sampling

Intervention Type OTHER

Maternal blood sampling

Interventions

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Blood sampling

Maternal blood sampling

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian SIDS and Stillbirth Society

OTHER

Sponsor Role collaborator

Extrastiftelsen

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Meryam Sugulle

Consultant Obstetrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryam Sugulle, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Department of Obstetrics

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Meryam Sugulle, PhD, MD

Role: CONTACT

Phone: +4722119800

Email: [email protected]

Anne Cathrine Staff, PhD, MD

Role: CONTACT

Phone: +4722119800

Email: [email protected]

Facility Contacts

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Meryam Sugulle, PhD, MD

Role: primary

Anne Cathrine Staff, PhD, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33990027 (View on PubMed)

Other Identifiers

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36259

Identifier Type: OTHER

Identifier Source: secondary_id

36864

Identifier Type: -

Identifier Source: org_study_id