Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study
Journal article, 2020

Introduction
First-trimester pregnancy risk evaluation facilitates individualised antenatal care, as well as application of preventive strategies for pre-eclampsia or birth of a small for gestational age infant. A range of early intervention strategies in pregnancies identified as high risk at the end of the first trimester has been shown to decrease the risk of preterm pre-eclampsia (<37 gestational weeks). The aim of this project is to create the Improving Maternal Pregnancy And Child ouTcomes (IMPACT) database; a nationwide database with individual patient data, including predictors recorded at the end of the first trimester and later pregnancy outcomes, to identify women at high risk of pre-eclampsia. A second aim is to link the IMPACT database to a biobank with first-trimester blood samples.
Methods and analysis
This is a Swedish prospective multicentre cohort study. Women are included between the 11th and 14th weeks of pregnancy. At inclusion, pre-identified predictors are retrieved by interviews and medical examinations. Blood samples are collected and stored in a biobank. Additional predictors and pregnancy outcomes are retrieved from the Swedish Pregnancy Register. Inclusion in the study began in November 2018 with a targeted sample size of 45 000 pregnancies by end of 2021. Creation of a new risk prediction model will then be developed, validated and implemented. The database and biobank will enable future research on prediction of various pregnancy-related complications.
Ethics and dissemination
Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (Uppsala 2018-231) and national biobank approval at Uppsala Biobank (18237 2 2018 231). Results from the current as well as future studies using information from the IMPACT database will be published in peer-reviewed journals.

first-trimester screening

placental growth factor

preeclampsia

mean arterial pressure

Author

Lina Bergman

University of Gothenburg

Anna Sandstrom

Karolinska Institutet

Uppsala University

Bo Jacobsson

University of Gothenburg

Stefan Hansson

Lund University

Skåne University Hospital

Peter Lindgren

Karolinska Institutet

Karolinska University Hospital

Anders Larsson

Uppsala University

Henrik Imberg

Chalmers, Mathematical Sciences, Applied Mathematics and Statistics

Peter Conner

Karolinska Institutet

Marius Kublickas

Karolinska University Hospital

Karolinska Institutet

Ylva Carlsson

University of Gothenburg

Anna-Karin Wikstrom

Uppsala University

BMJ Open

2044-6055 (ISSN)

Vol. 10 9 e033851

Subject Categories

Pediatrics

Environmental Health and Occupational Health

Obstetrics, Gynecology and Reproductive Medicine

DOI

10.1136/bmjopen-2019-033851

PubMed

32967865

More information

Latest update

11/24/2020