Study for Improving Maternal, Pregnancy and Child Outcomes (IMPACT)

May 8, 2024 updated by: Uppsala University

IMPACT - Study for Improving Maternal, Pregnancy and Child Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preeclampsia is a pregnancy-specific syndrome that affects 3-5% of all pregnancies and traditionally defined as new onset hypertension (blood pressure ≥ 140/90) and proteinuria after gestational week 20. The syndrome is one of the leading causes of maternal and perinatal acute morbidity and long-term disability and accounts for about 50 000 maternal deaths annually worldwide. Morbidity risks for the mother include seizures, intracranial hemorrhage, kidney failure, heart failure and pulmonary edema. Risks for the fetus include fetal growth restriction, preterm birth and hypoxia. Generally preterm preeclampsia (delivery before 37 weeks) is more severe than term preeclampsia.

Risk assessment for preeclampsia enables both prevention and early prediction of the disease.

Swedish risk assessment for preeclampsia in early pregnancy is still obtained by maternal history and characteristics, without medical examinations, which only detects about 30% of women that will develop preeclampsia. Risk factors are evaluated individually without being incorporated into a combined model that would allow multivariable analysis. This approach has been proven to be poor due to low specificity and sensitivity. Lately a more complex prediction model has been developed by the Fetal Medicine Foundation, using multivariable analysis and including serum biomarkers and physiological measurements reflecting maternal adaption to pregnancy. Intervention with aspirin given to identified high-risk pregnancies according this model has been shown to decrease the incidence of preterm (< 37 gestational weeks) preeclampsia (OR: 0.38; 95% CI 0.20-0.74), compared to placebo. Detection rates and cut-off values have been shown to vary between populations, depending on differences in population characteristics and incidence of disease, overfitting of the original model and differences in healthcare systems. Therefore, the model needs to be validated in Sweden. Further, the Fetal Medicine Foundation prediction model includes expensive covariates such as several biochemical markers and uterine artery Doppler. There is a need to create, validate and implement a cost-effective prediction model for first trimester screening for preeclampsia in a Swedish population, with the purpose to select who might benefit from aspirin prophylaxis to prevent preterm preeclampsia. We will study preeclampsia both according to the definition used in Sweden prior to 2020 and the definition used hereafter.

Early detection of preeclampsia remains one of the major focuses of maternal health care and is emphasized by the WHO, since it has proven to be beneficial for both the mother and unborn child. Small-for-gestational-age fetuses not identified before delivery have an increased risk of adverse perinatal outcomes, compared to those identified during pregnancy. Identification of high-risk pregnancies is therefore important in early pregnancy not only to plan for prophylactic interventions, but also to optimize surveillance and to plan deliveries. Today most Swedish women attend the same maternal health care program with increasing number of visits in the end of pregnancy. By risk identification in early pregnancy we can individualize maternal health care and target women at high risk early in pregnancy. High-risk pregnancies can be referred to specialized health care and normal pregnancies followed at the basic maternal health care.

The Swedish registry data is unique and combining it with a biobank containing blood samples from the first trimester could improve maternal healthcare and in the long run reduce adverse outcomes for Swedish women. A national first trimester pregnancy biobank would facilitate future research on prevention and prediction of pregnancy complications.

A total of 13000 enrolled individuals will be needed for creating the model and for validation.

Study Type

Observational

Enrollment (Actual)

13000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Falun, Sweden
        • County Council Dalarna
      • Gothenburg, Sweden
        • Gothenburg University, Sahlgrenska academy, dept of obstetrics and gynecology
      • Lund, Sweden
        • Lund University Hospital, dept of obstetrics and gynecology
      • Stockholm, Sweden
        • Karolinska Institute
      • Uppsala, Sweden
        • Uppsala University Hopsital, department of women's and children's health
      • Örebro, Sweden
        • Orebro University Hospital
    • Sörmland
      • Eskilstuna, Sörmland, Sweden
        • Eskilstuna Hospital
    • Västra Götalandsregionen
      • Borås, Västra Götalandsregionen, Sweden
        • Södra Älvsborgs Sjukhus
      • Trollhättan, Västra Götalandsregionen, Sweden
        • Norra Älvsborgs sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm Preeclampsia
Time Frame: delivery <37 gestational weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small for gestational age
Time Frame: at delivery
birthweight ≤ - 2 SD according to the Swedish reference curve
at delivery
Overall preeclampsia
Time Frame: At delivery
Preeclampsia according to the Swedish definition, currently new onset hypertension (blood pressure ≥ 140/90) and proteinuria after gestational week 20.
At delivery
Preterm preeclampsia
Time Frame: delivery <37 gestational weeks
Preeclampsia according to the Swedish definition prior to 2020 as well as the definition hereafter
delivery <37 gestational weeks
Term preeclampsia
Time Frame: delivery >/=37 gestational weeks
Preeclampsia according to the Swedish definition prior to 2020 as well as the definition hereafter
delivery >/=37 gestational weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Roche Pharma AG
Perkin Elmer Inc.
Thermo Fisher Scientific, Inc

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2018-231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available with a similar project in Denmark.

IPD Sharing Time Frame

2021

IPD Sharing Access Criteria

The steering committee will review requests. Requests can be sent to:

Anna-karin.wikstrom@kbh.uu.se or ylva.carlsson@vgregion.se

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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