Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study
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 e...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e033851.full |
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| author | Anders Larsson Henrik Imberg Marius Kublickas Anna-Karin Wikström Peter Lindgren Lina Bergman Bo Jacobsson Anna Sandström Stefan Hansson Peter Conner Ylva Carlsson |
| author_facet | Anders Larsson Henrik Imberg Marius Kublickas Anna-Karin Wikström Peter Lindgren Lina Bergman Bo Jacobsson Anna Sandström Stefan Hansson Peter Conner Ylva Carlsson |
| author_sort | Anders Larsson |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-f222b6e03d5d4bfea0c98621c401dde5 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f222b6e03d5d4bfea0c98621c401dde52025-01-07T10:25:08ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-033851Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort studyAnders Larsson0Henrik Imberg1Marius Kublickas2Anna-Karin Wikström3Peter Lindgren4Lina Bergman5Bo Jacobsson6Anna Sandström7Stefan Hansson8Peter Conner9Ylva Carlsson105Dept. of Medical Sciences, Section of Clinical Chemistry, Uppsala University, Uppsala, Sweden7 Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg Sahlgrenska Academy, Goteborg, Sweden3 Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Huddinge, SwedenDepartment of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden12 Center for Fetal Medicine, Karolinska University Hospital, Stockholm, SwedenDepartment of Obstetrics and Gynecology, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, SwedenDepartment of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, SwedenDepartment of Women’s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, SwedenDepartment of Clinical Sciences Lund, Obstetrics and Gynecology, Lunds Universitet, Lund, SwedenDepartment of Women’s and Children’s Health, Karolinska Institute, Stockholm, Stockholm County, SwedenDepartment of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenIntroduction 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.https://bmjopen.bmj.com/content/10/9/e033851.full |
| spellingShingle | Anders Larsson Henrik Imberg Marius Kublickas Anna-Karin Wikström Peter Lindgren Lina Bergman Bo Jacobsson Anna Sandström Stefan Hansson Peter Conner Ylva Carlsson Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study BMJ Open |
| title | Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study |
| title_full | Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study |
| title_fullStr | Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study |
| title_full_unstemmed | Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study |
| title_short | Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study |
| title_sort | study for improving maternal pregnancy and child outcomes impact a study protocol for a swedish prospective multicentre cohort study |
| url | https://bmjopen.bmj.com/content/10/9/e033851.full |
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