Clinical trial · Observational
PEPPI Study: Identification of Women at Risk for Placental Dysfunction
PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy
NCT06115122CI-TRIAL-00093101recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Hypertensive Disorder of Pregnancy | — | UNRESOLVED | — |
| Intrauterine Growth Restriction | — | UNRESOLVED | — |
| Iron-deficiency | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Pre-Eclampsia | — | UNRESOLVED | — |
| Proteinuria in Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-eclampsia screening program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Pre-eclampsia risk group
- description
- Approximately 300 women will be enrolled into a risk group according to a pre-eclampsia risk calculator.
- interventionNames
- Other: Pre-eclampsia screening program
- label
- PCOS group
- description
- Women enrolled into study who fulfill ≥2 Rotterdam criteria. Women with PCOS may be included in risk- or control groups.
- interventionNames
- Other: Pre-eclampsia screening program
- label
- Control group
- description
- Approximately 300 women in low risk for pre-eclampsia according to a pre-eclampsia risk calculator.
- interventionNames
- Other: Pre-eclampsia screening program
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Mothers Inclusion Criteria for PEPPI-study * Pregnant (first trimester) * Understands Finnish * ≥18 years * Signed informed consent Exclusion Criteria * Multiple pregnancy * Miscarriage/termination of the index pregnancy * No first trimester blood sampling Inclusion Criteria for FERPPI-study * 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 Exclusion Criteria * No first or third trimester blood sampling * No umbilical cord blood sample after baby is born Fathers Inclusion Criteria * Biological father to the child born for the mother who participated in PEPPI study * ≥18 years * Signed informed consent Exclusion Criteria • Does not understand Finnish Children Inclusion Criteria for PEPPI-study * Born to mother who participated in PEPPI study * Signed informed consent from parent(s) Exclusion Criteria • No consent from parent(s) Inclusion Criteria for PEPPI-offspring study • Mother in risk-, control-, or PCOS group during PEPPI-study with ultrasound information at gestational weeks 30-32 or a mother who developed pre-eclampsia during the pregnancy regardless of their study group during PEPPI-study Exclusion Criteria • Mother/father declines participation Inclusion Criteria for FERPPI-study * 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 * No consent from parent(s) * No blood samples from mother * No blood samples from child
References
Publications (23)
- BACKGROUNDAshraf UM, Hall DL, Rawls AZ, Alexander BT. Epigenetic processes during preeclampsia and effects on fetal development and chronic health. Clin Sci (Lond). 2021 Oct 15;135(19):2307-2327. doi: 10.1042/CS20190070. PMID 34643675
- BACKGROUNDBahri 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. PMID 30674081
- BACKGROUNDBecker M, Hesse V. Minipuberty: Why Does it Happen? Horm Res Paediatr. 2020;93(2):76-84. doi: 10.1159/000508329. Epub 2020 Jun 29. PMID 32599600
- BACKGROUNDBinder 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. PMID 27711226
- BACKGROUNDChockalingam 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. PMID 3612404
- BACKGROUNDDewey 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. PMID 29070565
- BACKGROUNDDuley 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.