PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

NCT03100084 | Unknown DMC

• 2 other identifiers: 3686436259
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Placental Insufficiency

Keywords

Preeclampsia; Diabetes in Pregnancy; Fetal Growth Restriction; Reduced Fetal Movements

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• 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

Study Arms (7)

I. Post Dates

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

Other: Blood sampling

II. Induction of Labour

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

Other: Blood sampling

III. All Outpatients

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

Other: Blood sampling

IV. Diabetes in Pregnancy

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

Other: 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

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

VII. All Labour Admissions

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

Other: Blood sampling

Interventions

Blood sampling OTHER

Maternal blood sampling

I. Post Dates; II. Induction of Labour; III. All Outpatients; IV. Diabetes in Pregnancy; V. Reduced Fetal Movements; VI. Hypertensive Disorders in Pregnancy; VII. All Labour Admissions

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Women who do not understand Norwegian or English
• Communicable disease
• Younger than 18 years of age
• Legally incompetent
• Fetal malformations

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian SIDS and Stillbirth Society: collaborator
• Extrastiftelsen: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0407, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 33990027 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Maternal plasma, serum and DNA

MeSH Terms

Conditions

Pregnancy Complications; Placental Insufficiency; Pre-Eclampsia; Diabetes, Gestational; Fetal Growth Retardation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Meryam Sugulle, PhD, MD

  Oslo University Hospital, Department of Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meryam Sugulle, PhD, MD

CONTACT

+4722119800; uxsume@ous-hf.no

Anne Cathrine Staff, PhD, MD

CONTACT

+4722119800; uxnnaf@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 4, 2017
• Study Start: September 15, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

NO (1)