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| ID | Type | Description | Link |
|---|---|---|---|
| 36259 | Other Identifier | Oslo University Hospital |
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| Name | Class |
|---|---|
| Norwegian SIDS and Stillbirth Society | OTHER |
| Extrastiftelsen | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I. Post Dates | Pregnant women referred for clinical post term evaluation and/or labour induction. Blood sampling. |
| |
| II. Induction of Labour | Pregnant women ≥37+0 GW (gestational week) referred for labour induction (any cause). Blood sampling. |
| |
| III. All Outpatients | Pregnant women ≥37+0 GW presenting for any medical reason at OUH outpatient clinic. Blood sampling |
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| IV. Diabetes in Pregnancy | Pregnant women ≥36+0 GW with pregestational or gestational diabetes. Blood sampling. |
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| V. Reduced Fetal Movements | 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 | Pregnant women referred for preeclampsia (or other pregnancy induced hypertensive disorders) and/or suspected fetal growth restriction; longitudinal cohorts. Blood sampling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Maternal blood sampling |
|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meryam Sugulle, PhD, MD | Contact | +4722119800 | uxsume@ous-hf.no | |
| Anne Cathrine Staff, PhD, MD | Contact | +4722119800 | uxnnaf@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Meryam Sugulle, PhD, MD | Oslo University Hospital, Department of Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33990027 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D010927 | Placental Insufficiency |
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Maternal plasma, serum and DNA
|
| VII. All Labour Admissions | All pregnant women ≥37+0 GW admitted for labour. Blood sampling. |
|
| 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 |
| Abnormal intrapartum CTG patterns | Intrapartum CTG; data assessed throughout study period of 140 months |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |