Study for Improving Maternal, Pregnancy and Child Outcomes

NCT03831490 | Completed DMC

• 1 other identifier: Dnr 2018-231
• Study Type: observational
• Target: 13,000
• Locations: 1 country
• Sites: 9

Brief 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. 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. 2.Validating the Fetal Medicine Foundation prediction model for detection of preterm (\< 37 gestational weeks) preeclampsia in a Swedish population.
3. 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. 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

Keywords

screening; biomarkers; prediction

Outcome Measures

Primary Outcomes (1)

• Preterm Preeclampsia

  Preeclampsia according to the Swedish definition, currently new onset hypertension (blood pressure ≥ 140/90) and proteinuria after gestational week 20.

  delivery <37 gestational weeks

Secondary Outcomes (4)

• Small for gestational age

  at delivery

• Overall preeclampsia

  At delivery

• Preterm preeclampsia

  delivery <37 gestational weeks

• Term preeclampsia

  delivery >/=37 gestational weeks

Interventions

history DIAGNOSTIC_TEST

combining these 4 interventions will great an algorithm predicting preeclampsia

Also known as: mean material blod pressure, PlGF - blood sample, a- uterine doppler

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women attending a first trimester ultrasound at the study sites, which involves both tertiary as well as secondary hospitals and out-patient clinics.

You may qualify if:

• Women with a Swedish personal identity number, who adhere to maternal care program before the end of the first trimester and have a planned first trimester scan (weeks 11-13) are eligible for the study.

You may not qualify if:

• Maternal age \<18 years or language-barrier despite interpreter and written information.

Sponsors & Collaborators

• Uppsala University: lead
• Thermo Fisher Scientific, Inc: collaborator
• Perkin Elmer Inc.: collaborator
• Roche Pharma AG: collaborator

Study Sites (9)

Eskilstuna hospital

Eskilstuna, Sörmland, Sweden

Location

Södra Älvsborgs sjukhus

Borås, Västra Götalandsregionen, Sweden

Location

Norra Älvsborgs sjukhus

Trollhättan, Västra Götalandsregionen, Sweden

Location

County Council Dalarna

Falun, Sweden

Location

Gothenburg University, Sahlgrenska academy, dept of obstetrics and gynecology

Gothenburg, Sweden

Location

Lund University Hospital, dept of obstetrics and gynecology

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska Institute

Stockholm, Sweden

Location

Uppsala University Hopsital, department of women's and children's health

Uppsala, Sweden

Location

Related Publications (14)

• Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7. doi: 10.1053/j.semperi.2009.02.010.

  PMID: 19464502 RESULT

• Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.

  PMID: 26342729 RESULT

• Wikstrom AK, Larsson A, Eriksson UJ, Nash P, Norden-Lindeberg S, Olovsson M. Placental growth factor and soluble FMS-like tyrosine kinase-1 in early-onset and late-onset preeclampsia. Obstet Gynecol. 2007 Jun;109(6):1368-74. doi: 10.1097/01.AOG.0000264552.85436.a1.

  PMID: 17540809 RESULT

• Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25.

  PMID: 25724400 RESULT

• Akolekar R, Syngelaki A, Poon L, Wright D, Nicolaides KH. Competing risks model in early screening for preeclampsia by biophysical and biochemical markers. Fetal Diagn Ther. 2013;33(1):8-15. doi: 10.1159/000341264. Epub 2012 Aug 16.

  PMID: 22906914 RESULT

• Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

  PMID: 28657417 RESULT

• Mosimann B, Pfiffner C, Amylidi-Mohr S, Risch L, Surbek D, Raio L. First trimester combined screening for preeclampsia and small for gestational age - a single centre experience and validation of the FMF screening algorithm. Swiss Med Wkly. 2017 Aug 25;147:w14498. doi: 10.4414/smw.2017.14498. eCollection 2017.

  PMID: 28871576 RESULT

• Oliveira N, Magder LS, Blitzer MG, Baschat AA. First-trimester prediction of pre-eclampsia: external validity of algorithms in a prospectively enrolled cohort. Ultrasound Obstet Gynecol. 2014 Sep;44(3):279-85. doi: 10.1002/uog.13435. Epub 2014 Aug 13.

  PMID: 24913190 RESULT

• O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19.

  PMID: 26297382 RESULT

• WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/

  PMID: 23741776 RESULT

• Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. doi: 10.1002/uog.1806.

  PMID: 15717289 RESULT

• Sreeja Sarojini AG, Andrew Pecora and K. Stephen Suh. Proactive Biobanking to Improve Research and Health Care. Journal of Tissue Science & Engineering.

  RESULT

• Stephansson O, Petersson K, Bjork C, Conner P, Wikstrom AK. The Swedish Pregnancy Register - for quality of care improvement and research. Acta Obstet Gynecol Scand. 2018 Apr;97(4):466-476. doi: 10.1111/aogs.13266. Epub 2017 Dec 14.

  PMID: 29172245 RESULT

• Bergman L, Sandstrom A, Jacobsson B, Hansson S, Lindgren P, Larsson A, Imberg H, Conner P, Kublickas M, Carlsson Y, Wikstrom AK. Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study. BMJ Open. 2020 Sep 23;10(9):e033851. doi: 10.1136/bmjopen-2019-033851.

  PMID: 32967865 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

At centers with biobank possibilities, serum, plasma and buffy-coat samples will be collected at the same time as the serum sample for analyze of Placental Growth Factor. The samples for the biobank will be stored for future research related to prediction, diagnosis and prevention of pregnancy complications.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lina Bergman, MD, PhD

  Uppsala University

  STUDY CHAIR

• Peter Lindgren, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Anna Sandström, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Peter Conner, Ass Prof

  Karolinska Institutet

  STUDY CHAIR

• Marius Kublickas, Ass Prof

  Karolinska Institutet

  STUDY CHAIR

• Stefan Hansson, Professor

  Lund University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: November 9, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2021
• Access Criteria: The steering committee will review requests. Requests can be sent to: Anna-karin.wikstrom@kbh.uu.se or ylva.carlsson@vgregion.se

Locations

SE (9)