PEPPI Study: Identification of Women at Risk for Placental Dysfunction
NCT ID: NCT06115122
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2022-02-15
2041-12-31
Brief Summary
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Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome
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Detailed Description
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Studies within PEPPI-study:
PEPPI-offspring: Children born for those 600 women in risk-, control and PCOS groups who have an extra ultrasound at gestational weeks 30-32 during PEPPI-study and children whose mother developed pre-eclampsia during the pregnancy regardless of her study group during PEPPI-study are recruited into PEPPI-offspring study. PEPPI-offspring study investigates the short- and long-term consequences of placental insufficiency/pre-eclampsia on the health of the children.
PEPPI-PCOS: Investigates pregnancy characteristics of women with PCOS. Women with PCOS form PCOS study group, have additional ultrasound scan at gestational weeks 30-32 and their children are recruited into PEPPI-offspring study.
FERPPI: FERPPI study investigates the possible connection between placental insufficiency and iron deficiency with or without anemia in both pregnant women and their children after birth.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pre-eclampsia risk group
Approximately 300 women will be enrolled into a risk group according to a pre-eclampsia risk calculator.
Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
PCOS group
Women enrolled into study who fulfill ≥2 Rotterdam criteria. Women with PCOS may be included in risk- or control groups.
Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Control group
Approximately 300 women in low risk for pre-eclampsia according to a pre-eclampsia risk calculator.
Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Follow up group
Approximately 2100 women who are not enrolled into risk-, control- or PCOS groups.
Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Children
Mothers and fathers will be asked for permission to follow the child's health information from national registers until the age of 15 years. Approximately 300 children will be recruited to PEPPI-offspring follow up study (including also PCOS offspring).
No interventions assigned to this group
Fathers
The role of fathers in the development of pregnancy complications and on the health of the offspring.
No interventions assigned to this group
Interventions
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Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Eligibility Criteria
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Inclusion Criteria
* Understands Finnish
* ≥18 years
* Signed informed consent
* Participates in PEPPI-study (criteria above)
* Blood samples at first and third trimester of pregnancy
* Permits blood sampling from the umbilical cord when the baby is born
* Biological father to the child born for the mother who participated in PEPPI study
* ≥18 years
* Signed informed consent
* Born to mother who participated in PEPPI study
* Signed informed consent from parent(s)
* Signed informed consent from parent(s)
* Mother has blood samples taken at first and third trimester (iron status)
* Child has blood samples taken at birth and at 3 months of age
Exclusion Criteria
* Miscarriage/termination of the index pregnancy
* No first trimester blood sampling
* No first or third trimester blood sampling
* No umbilical cord blood sample after baby is born
Fathers
• Does not understand Finnish
Children
• No consent from parent(s)
• Mother/father declines participation
* No consent from parent(s)
* No blood samples from mother
* No blood samples from child
ALL
Yes
Sponsors
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PerkinElmer, Inc.
INDUSTRY
Roche Diagnostics GmbH
INDUSTRY
Academy of Finland
OTHER
Sigrid Jusélius Foundation
OTHER
Finnish Medical Foundation
NETWORK
University of Oulu
OTHER
Oulu University Hospital
OTHER
Responsible Party
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Jaana Nevalainen
Associate professor
Principal Investigators
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Jaana Nevalainen, Assoc prof
Role: PRINCIPAL_INVESTIGATOR
The Wellbeing Services County of North Ostrobothnia
Locations
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The Wellbeing Services County of North Ostrobothnia
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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References
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Bahri Khomami M, Joham AE, Boyle JA, Piltonen T, Silagy M, Arora C, Misso ML, Teede HJ, Moran LJ. Increased maternal pregnancy complications in polycystic ovary syndrome appear to be independent of obesity-A systematic review, meta-analysis, and meta-regression. Obes Rev. 2019 May;20(5):659-674. doi: 10.1111/obr.12829. Epub 2019 Jan 23.
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Binder NK, Evans J, Salamonsen LA, Gardner DK, Kaitu'u-Lino TJ, Hannan NJ. Placental Growth Factor Is Secreted by the Human Endometrium and Has Potential Important Functions during Embryo Development and Implantation. PLoS One. 2016 Oct 6;11(10):e0163096. doi: 10.1371/journal.pone.0163096. eCollection 2016.
Chockalingam UM, Murphy E, Ophoven JC, Weisdorf SA, Georgieff MK. Cord transferrin and ferritin values in newborn infants at risk for prenatal uteroplacental insufficiency and chronic hypoxia. J Pediatr. 1987 Aug;111(2):283-6. doi: 10.1016/s0022-3476(87)80088-4.
Dewey KG, Oaks BM. U-shaped curve for risk associated with maternal hemoglobin, iron status, or iron supplementation. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1694S-1702S. doi: 10.3945/ajcn.117.156075. Epub 2017 Oct 25.
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.
Duley L, Henderson-Smart DJ, Meher S, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004659. doi: 10.1002/14651858.CD004659.pub2.
Guy GP, Leslie K, Diaz Gomez D, Forenc K, Buck E, Khalil A, Thilaganathan B. Implementation of routine first trimester combined screening for pre-eclampsia: a clinical effectiveness study. BJOG. 2021 Jan;128(2):149-156. doi: 10.1111/1471-0528.16361. Epub 2020 Jul 1.
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Koster MP, de Wilde MA, Veltman-Verhulst SM, Houben ML, Nikkels PG, van Rijn BB, Fauser BC. Placental characteristics in women with polycystic ovary syndrome. Hum Reprod. 2015 Dec;30(12):2829-37. doi: 10.1093/humrep/dev265. Epub 2015 Oct 25.
Nevalainen J, Korpimaki T, Kouru H, Sairanen M, Ryynanen M. Performance of first trimester biochemical markers and mean arterial pressure in prediction of early-onset pre-eclampsia. Metabolism. 2017 Oct;75:6-15. doi: 10.1016/j.metabol.2017.07.004. Epub 2017 Jul 18.
Nevalainen J, Skarp S, Savolainen ER, Ryynanen M, Jarvenpaa J. Intrauterine growth restriction and placental gene expression in severe preeclampsia, comparing early-onset and late-onset forms. J Perinat Med. 2017 Oct 26;45(7):869-877. doi: 10.1515/jpm-2016-0406.
O'Gorman N, Wright D, Rolnik DL, Nicolaides KH, Poon LC. Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment with ASpirin for evidence-based PREeclampsia prevention (ASPRE). BMJ Open. 2016 Jun 28;6(6):e011801. doi: 10.1136/bmjopen-2016-011801.
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.
Santos DCC, Angulo-Barroso RM, Li M, Bian Y, Sturza J, Richards B, Lozoff B. Timing, duration, and severity of iron deficiency in early development and motor outcomes at 9 months. Eur J Clin Nutr. 2018 Mar;72(3):332-341. doi: 10.1038/s41430-017-0015-8. Epub 2017 Nov 6.
Shanmugalingam R, Hennessy A, Makris A. Aspirin in the prevention of preeclampsia: the conundrum of how, who and when. J Hum Hypertens. 2019 Jan;33(1):1-9. doi: 10.1038/s41371-018-0113-7. Epub 2018 Sep 19.
Shao J, Lou J, Rao R, Georgieff MK, Kaciroti N, Felt BT, Zhao ZY, Lozoff B. Maternal serum ferritin concentration is positively associated with newborn iron stores in women with low ferritin status in late pregnancy. J Nutr. 2012 Nov;142(11):2004-9. doi: 10.3945/jn.112.162362. Epub 2012 Sep 26.
Tal R, Seifer DB, Grazi RV, Malter HE. Follicular fluid placental growth factor is increased in polycystic ovarian syndrome: correlation with ovarian stimulation. Reprod Biol Endocrinol. 2014 Aug 20;12:82. doi: 10.1186/1477-7827-12-82.
Tan MY, Wright D, Syngelaki A, Akolekar R, Cicero S, Janga D, Singh M, Greco E, Wright A, Maclagan K, Poon LC, Nicolaides KH. Comparison of diagnostic accuracy of early screening for pre-eclampsia by NICE guidelines and a method combining maternal factors and biomarkers: results of SPREE. Ultrasound Obstet Gynecol. 2018 Jun;51(6):743-750. doi: 10.1002/uog.19039. Epub 2018 Mar 14.
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Yliniemi A, Nurkkala MM, Kopman S, Korpimaki T, Kouru H, Ryynanen M, Marttala J. First trimester placental retinol-binding protein 4 (RBP4) and pregnancy-associated placental protein A (PAPP-A) in the prediction of early-onset severe pre-eclampsia. Metabolism. 2015 Apr;64(4):521-6. doi: 10.1016/j.metabol.2014.12.008. Epub 2014 Dec 26.
Related Links
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PEPPI-study's webpage
Other Identifiers
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OuluUH_PEPPI
Identifier Type: -
Identifier Source: org_study_id
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