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PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome (PREPPeD)

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ClinicalTrials.gov Identifier: NCT03100084
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Norwegian SIDS and Stillbirth Society
Extrastiftelsen
Information provided by (Responsible Party):
Meryam Sugulle, 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.

Condition or disease Intervention/treatment
Pregnancy Complications Placental Insufficiency 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
Actual Study Start Date : September 15, 2016
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.)


  2. 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

  3. 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

  4. Rate of intrauterine fetal demise/intra-/postpartum fetal death [ Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months ]
  5. Neonatal intubation/mechanical ventilation>6 hours [ Time Frame: Within 28 days postpartum; data assessed throughout study period of 140 months ]
  6. Meconium aspiration syndrome [ Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months ]
  7. Neonatal hypoxic-ischemic encephalopathy [ Time Frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months ]
  8. Therapeutic hypothermia of the neonate [ Time Frame: Within 3 days postpartum; data assessed throughout study period of 140 months ]
  9. Rate of acute cesarean section (due to suspected fetal distress) [ Time Frame: Data assessed throughout study period of 140 months ]

Secondary Outcome Measures :
  1. Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) [ Time Frame: Data assessed throughout study period of 140 months ]
  2. Pathological placenta histology findings [ Time Frame: Data assessed throughout study period of 140 months ]
  3. Abnormal intrapartum CTG patterns [ Time Frame: Intrapartum CTG; data assessed throughout study period of 140 months ]

Biospecimen Retention:   Samples With DNA
Maternal plasma, serum and DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100084


Contacts
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Contact: Meryam Sugulle, PhD, MD +4722119800 uxsume@ous-hf.no
Contact: Anne Cathrine Staff, PhD, MD +4722119800 uxnnaf@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Meryam Sugulle, PhD, MD    +4722119800    uxsume@ous-hf.no   
Contact: Anne Cathrine Staff, PhD, MD    +4722119800    uxnnaf@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian SIDS and Stillbirth Society
Extrastiftelsen
Investigators
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Principal Investigator: Meryam Sugulle, PhD, MD Oslo University Hospital, Department of Obstetrics
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Responsible Party: Meryam Sugulle, Consultant Obstetrician, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03100084    
Other Study ID Numbers: 36864
36259 ( Other Identifier: Oslo University Hospital )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meryam Sugulle, Oslo University Hospital:
Preeclampsia
Diabetes in Pregnancy
Fetal Growth Restriction
Reduced Fetal Movements
Additional relevant MeSH terms:
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Pregnancy Complications
Placental Insufficiency
Placenta Diseases