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

Bergman, Lina ; Sandström, Anna ; Jacobsson, Bo ; Hansson, Stefan LU orcid ; Lindgren, Peter ; Larsson, Anders ; Imberg, Henrik ; Conner, Peter ; Kublickas, Marius and Carlsson, Ylva , et al. (2020) In BMJ Open 10(9).
Abstract

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... (More)

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. TRIAL REGISTRATION NUMBER: NCT03831490.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
first-trimester screening, mean arterial pressure, placental growth factor, preeclampsia
in
BMJ Open
volume
10
issue
9
article number
e033851
publisher
BMJ Publishing Group
external identifiers
  • scopus:85091541809
  • pmid:32967865
ISSN
2044-6055
DOI
10.1136/bmjopen-2019-033851
language
English
LU publication?
yes
id
903aaf73-cfbf-4b49-a6b0-9cdefc815f09
date added to LUP
2020-10-23 15:00:10
date last changed
2024-04-03 16:18:11
@article{903aaf73-cfbf-4b49-a6b0-9cdefc815f09,
  abstract     = {{<p>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 (&lt;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. TRIAL REGISTRATION NUMBER: NCT03831490.</p>}},
  author       = {{Bergman, Lina and Sandström, Anna and Jacobsson, Bo and Hansson, Stefan and Lindgren, Peter and Larsson, Anders and Imberg, Henrik and Conner, Peter and Kublickas, Marius and Carlsson, Ylva and Wikström, Anna Karin}},
  issn         = {{2044-6055}},
  keywords     = {{first-trimester screening; mean arterial pressure; placental growth factor; preeclampsia}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT) : a study protocol for a Swedish prospective multicentre cohort study}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2019-033851}},
  doi          = {{10.1136/bmjopen-2019-033851}},
  volume       = {{10}},
  year         = {{2020}},
}