Predicting Late-onset Preeclampsia at 10-14 Weeks of Pregnancy

NCT04075708 | Completed

• 1 other identifier: 2019-031 PIKBF PRESIDE
• Study Type: observational
• Target: 1,427
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to make it easier to predict late-onset preeclampsia at 11-14 weeks of pregnancy. This will be done by measuring certain proteins in the mother's blood together with obtaining the mother's medical history, ultrasound of the mother's blood supply to the uterus, and her blood pressure. All expectant mothers who meet the inclusion criteria will be invited to participate in the study, and those that agree will have the above mentioned factors measured at their first trimester scan appointment. The data will be registered in an online database, and the blood samples will be saved in a biobank at the hospital. When the women have then given birth around six months later, the data will be analyzed, and whether or not the individual woman ended up developing preeclampsia will be found out from her medical records. It will then be possible to see if blood samples, medical history, blood supply to the uterus, and/or blood pressure are connected to development of preeclampsia.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Late-onset preeclampsia

  Diagnosis of pre-eclampsia \>34 weeks of pregnancy

  After delivery of the child, i.e. an average of 6 months from enrollment

Secondary Outcomes (4)

• Fetal growth restriction

  After delivery of the child, i.e. an average of 6 months from enrollment

• Gestational hypertension

  After delivery of the child, i.e. an average of 6 months from enrollment

• Apgar score

  After delivery of the child, i.e. an average of 6 months from enrollment

• Method of delivery

  After delivery of the child, i.e. an average of 6 months from enrollment

Study Arms (2)

Case-group

The case group will consist of women diagnosed with PE after 34 weeks of gestation.

Control-group

The control group will include 165 participants who were not diagnosed with PE in their pregnancies.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort consists of pregnant women assigned to the Department of Obstetrics at Odense University Hospital for their first trimester nuchal translucency between September 2019 and March 2020; who are included/excluded according to the criteria below; and who agree to enroll in the study.

You may qualify if:

• A planned first trimester nuchal translucency scan
• Informed consent
• Gestational age 11-14 weeks at the first trimester scan

You may not qualify if:

• Age \< 18 years
• ≥ 2 fetuses
• Participants must read and understand Danish or English

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

0.5 mL serum

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lene Sperling, M.D., PhD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: September 3, 2019
• Study Start: August 13, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2019-11

Locations

DK (1)