Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016

Papa Giovanni XXIII Hospital

Status: Completed

Conditions: Preeclampsia/Eclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT02982265

Reg. 2016/0161

Details and patient eligibility

About

Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies and remains a leading cause of maternal and perinatal mortality and morbidity.

Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein concentration ≥ 300 mg/L or ≥ "1 +" on dipstick in at least two random urine samples taken at least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.

Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the same. However, the underlying causes of the disease remain largely unknown.

Full description

Poor placentation is considered a powerful predisposing factor for pre-eclampsia. Recently, it has been suggested that the occurrence of pre-eclampsia requires a combination of an excessive or atypical maternal immune response to the trophoblast and/or exaggerated endothelial activation as well as a generalised hyper-inflammatory state resulting in endothelial dysfunction and associated increased vascular reactivity. Any factors (maternal and paternal constitutional, genetic and environmental risk factors) that enhance these responses would predispose to pre-eclampsia.

The list of predisposing factors includes: extremes of maternal age, black race, previous history of pre-eclampsia, family history of pre-eclampsia, multifetal gestation, ≥ 10 years from previous pregnancy, limited sperm exposure, first paternity, pregnancies after donor insemination (assisted reproductive technology), oocyte donation or embryo donation, chronic hypertension or renal disease, rheumatic disease, maternal low birth weight, obesity and insulin resistance, pre-gestational diabetes mellitus, increased testosterone, increased homocysteine concentration, atherosclerosis (increased triglycerides and LDL, decreased HDL), maternal infections, pre-existing thrombophilia, maternal susceptibility genes and hydropic degeneration of placenta. Finally, smoking seems to be inversely correlated with pre-eclampsia.

Pre-eclampsia can result in a fetal syndrome characterized by fetal growth restriction, reduced amniotic fluid, abnormal oxygenation, fetal demise and preterm birth. Moreover, women with pre-eclampsia are at increased risk for abruptio placentae, disseminated coagulopathy/HELLP syndrome, pulmonary oedema, acute renal failure, eclampsia, cerebral haemorrhage, death and cardiovascular or renal disease.

Early prediction of pre-eclampsia would allow for close surveillance and preventive strategies

Enrollment: 1,527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to read and understand the Italian language and fill in the questionnaire, including access to the Internet.
• Ability of both parents to give informed consent to the processing of personal data, with the understanding that the consent could be withdrawn at any time

Exclusion criteria

• Inability to reach the patients by telephone and inform them about the study
• Death or incapacitating illness of one or both parents following discharge from hospital
• Refusal of one or both parents to disclose their email address