PEPPI Study: Identification of Women at Risk for Placental Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-eclampsia screening program.
- Who it may be relevant to
- Registry conditions: Pre-Eclampsia, Intrauterine Growth Restriction, Polycystic Ovary Syndrome, Iron-deficiency. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy
Overview
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
Detailed description
According to power calculations, altogether 3000 pregnant women will be recruited into PEPPI-study in Oulu area. Women will be recruited during their first visit to maternity care. Women will have blood samples for study purposes at first and third trimester of pregnancy. Participants will be divided into risk-, control- and polycystic ovary syndrome (PCOS) groups according to pre-eclampsia risk calculation program and questionnaire (PCOS: Rotterdam criteria) (N=300/group). Half of the women in risk- and control groups and all women in PCOS group will have a pregnancy ultrasound scan at 30-32 weeks of gestation. Fathers and children will be recruited at the Oulu University Hospital when the child is born.
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.
Interventions
- Other Pre-eclampsia screening program
Pregnant women will be devided into risk-, control- and PCOS groups according to first trimester screening program.
Primary outcome measures
- Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate [Time frame: 20 weeks through discharge following delivery]
- Severe Hypertension [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32-34-37 Weeks of Gestation Owing to Hypertension-related Disorders [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the - 2 SD) Adjusted for Sex and Race or Ethnic Group [Time frame: 20 weeks through discharge following delivery]
- Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death [Time frame: 20 weeks through discharge or prior to discharge following delivery admission]
- Prevalence of high pre-eclampsia risk score in women with PCOS compared to non-PCOS women [Time frame: at 13 gestational weeks]
Secondary outcome measures (12)
- Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia). [Time frame: 20 weeks through discharge following delivery.]
- Superimposed Pre-eclampsia (Mild, Severe, HELLP Syndrome, Eclampsia). [Time frame: 20 weeks through discharge following delivery.]
- Pregnancy Associated Hypertension. [Time frame: 20 weeks through discharge following delivery.]
- Medically Indicated Delivery Because of Hypertension. [Time frame: 20 weeks through discharge following delivery.]
- Fetal Weight Estimation under 3rd percentile at gestational weeks 30-32 ultrasound scan. [Time frame: 30-32 weeks.]
- Abnormal uterine artery pulsatility index at gestational weeks 30-32 ultrasound scan [Time frame: At 30-32 weeks.]
- Aspartate Aminotransferase ≥100 U/Liter. [Time frame: 20 weeks through discharge.]
- Creatinine ≥90 µmol/l. [Time frame: 20 weeks through discharge.]
- Massive postpartum hemorrhage. [Time frame: From delivery to 24 hours after child birth]
- Premature Rupture of Membranes. [Time frame: From 22nd gestational week until delivery]
- Placental Abruption. [Time frame: From 22nd gestational week until delivery]
- Gestational Diabetes. [Time frame: From gestation until delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- The Wellbeing Services County of North Ostrobothnia — Oulu
Publications
- Ashraf 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
- 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. PMID 30674081
- Becker 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
- 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. PMID 27711226
- 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. PMID 3612404
- 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. PMID 29070565
- 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
- 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. PMID 17443552
Identifiers
NCT: NCT06115122 · OuluUH_PEPPI