Clinical trial NCT02982265: Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016
Official title: "Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016" Retrospective Observational Multicenter Study Carried Out Through an On-line Self-administered Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia/Eclampsia
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 1527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Women discharged from the enrolling Centres with a diagnosis of preeclampsia and/or eclampsia over the years 2010-2016, identified by the ICD-9-CM codes 642.4 to 642.44, 642.5 to 642.54, 642.6 to 642.64 and 642.7 to 642.74.
* Fathers

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of preeclampsia/eclampsia in Italy
timeFrame: Three months
measure: Aggregation of predisposing factors to pre-eclampsia / eclampsia in Italy measured by a novel multiple choice on-line questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Maternal outcomes measured by a novel multiple choice on-line questionnaire
timeFrame: Three months
measure: Fetal outcomes measured by a novel multiple choice on-line questionnaire
timeFrame: Three months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii
Study officials:
affiliation: ASST Papa Giovanni XXIII, Bergamo, Italy
name: Chiara Viviani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: