Study for Improving Maternal, Pregnancy and Child Outcomes

NCT03831490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13000

Last updated 2024-05-09

No results posted yet for this study

Summary

The overall aims of this proposal are to improve, facilitate, optimize and equalize the existing screening system for adverse pregnancy outcomes in early pregnancy in order to limit adverse consequences for both the mother and infant, by:

1. Creating a Swedish prediction model with population-specific risk factors, optimized for the Swedish health care system, identifying high-risk women for preterm preeclampsia and validate the model within the cohort. This would give us the possibility to start aspirin prophylaxis in time, which has been proven to reduce the risk of developing preterm preeclampsia by 50%.
2. Validating the Fetal Medicine Foundation prediction model for detection of preterm (\< 37 gestational weeks) preeclampsia in a Swedish population.
3. Creating a prediction model identifying high-risk women for overall preeclampsia during pregnancy and birth of a small for gestational age infant in order to plan individualized surveillance for early detection, which has been proven beneficial for both the mother and infant.
4. Creating a national pregnancy biobank with blood samples and individual clinical registry data, including pregnancy outcomes, enabling future research on prevention and early detection for various adverse pregnancy outcomes which could be such as preterm birth and intrauterine growth restriction.

Conditions

  • Pre-Eclampsia

Interventions

DIAGNOSTIC_TEST

history

combining these 4 interventions will great an algorithm predicting preeclampsia

Sponsors & Collaborators

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY
  • Perkin Elmer Inc.

    collaborator INDUSTRY
  • Roche Pharma AG

    collaborator INDUSTRY
  • Uppsala University

    lead OTHER

Principal Investigators

  • Lina Bergman, MD, PhD · Uppsala University

  • Peter Lindgren, MD, PhD · Karolinska Institutet

  • Anna Sandström, MD, PhD · Karolinska Institutet

  • Peter Conner, Ass Prof · Karolinska Institutet

  • Marius Kublickas, Ass Prof · Karolinska Institutet

  • Stefan Hansson, Professor · Lund University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831490 on ClinicalTrials.gov