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

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ClinicalTrials.gov Identifier: NCT03831490
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Thermo Fisher Scientific
Perkin Elmer Inc.
Roche Pharma AG
Information provided by (Responsible Party):
Uppsala University

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. 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.

Condition or disease Intervention/treatment
Pre-Eclampsia Diagnostic Test: history

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, heat failure and pulmonary edema. Risks for the fetus include fetal growth restriction preterm birth and hypoxia. Generally preterm preeclampsia (<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.

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 46250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: IMPACT - Study for Improving Maternal, Pregnancy and Child Outcomes
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : November 9, 2020
Estimated Study Completion Date : June 9, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: history
    combining these 4 interventions will great an algorithm predicting preeclampsia
    Other Names:
    • mean material blod pressure
    • PlGF - blood sample
    • a- uterine doppler


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Small for gestational age [ Time Frame: at delivery ]
    birthweight ≤ - 2 SD according to the Swedish reference curve

  2. 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.

  3. Early preeclampsia [ Time Frame: delivery <34 gestational weeks ]
    Preeclampsia according to the Swedish definition, currently new onset hypertension (blood pressure ≥ 140/90) and proteinuria after gestational week 20.

  4. Term 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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831490


Contacts
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Contact: Anna-Karin Wikström, Professor +46768498607 Anna-karin.wikstrom@kbh.uu.se
Contact: Ylva K Carlsson, MD, PhD +46793641240 ylva.carlsson@vgregion.se

Locations
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Sweden
County Council Dalarna Recruiting
Falun, Sweden
Contact: Lina Bergman, MD, PhD         
Principal Investigator: LIna Bergman, MD, PhD         
Gothenburg University, Sahlgrenska academy, dept of obstetrics and gynecology Recruiting
Gothenburg, Sweden
Contact: Ylva Carlsson, MD, PhD         
Principal Investigator: Ylva Carlsson, MD, PhD         
Sub-Investigator: Bo Jacobsson, professor         
Lund University Hospital, dept of obstetrics and gynecology Recruiting
Lund, Sweden
Contact: Stefan Hansson, professor         
Principal Investigator: Stefan Hansson, professor         
Karolinska Institute Not yet recruiting
Stockholm, Sweden
Contact: Anna Sandström, MD, PhD         
Sub-Investigator: Anna Sandström, MD, PhD         
Principal Investigator: Peter Lindgren, MD, PhD         
Sub-Investigator: Peter Conner, ass prof         
Sub-Investigator: Marius Kublickas, ass prof         
Uppsala University Hopsital, department of women's and children's health Recruiting
Uppsala, Sweden
Contact: Anna Karin Wikström, professor         
Principal Investigator: Anna Karin Wikström, professor         
Sponsors and Collaborators
Uppsala University
Thermo Fisher Scientific
Perkin Elmer Inc.
Roche Pharma AG
Investigators
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Study Chair: Lina Bergman, MD, PhD Uppsala University
Study Chair: Bo Jacobsson, Professor Sahlgrenska Academy, Gothenburg 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

Additional Information:

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

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03831490     History of Changes
Other Study ID Numbers: Dnr 2018-231
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD and related data dictionaries available with a similar project in Denmark.
Supporting Materials: Clinical Study Report (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

URL: http://www.impactstudien.se

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:
screening
biomarkers
prediction

Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications