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

NCT02982265 | Completed

• 1 other identifier: Reg. 2016/0161
• Study Type: observational
• Target: 1,527
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia/Eclampsia

Outcome Measures

Primary Outcomes (2)

• Incidence of preeclampsia/eclampsia in Italy

  Three months

• Aggregation of predisposing factors to pre-eclampsia / eclampsia in Italy measured by a novel multiple choice on-line questionnaire

  Either, or maternal and paternal: extremes of age (years), extremes of weight (BMI in kg/m2), blood group, ethnic group, level of education (primary, secondary or academic), cardiovascular predisposing factors (hypertension defined as over 140/90 mmHg BP, diabetes mellitus defined as fasting glycemia over 126 mg/dl or over 200mg/dl in a glucose tolerance test, hypercholesterolemia defined as LDL over 240mg/dl, hyperhomocysteinemia defined as homocysteinemia over 15 mol/l, cigarette smoking), family history of pre-eclampsia/eclampsia and/or of cardiovascular predisposing factors (as above), presence of rheumatological and/or immunological disorders, pre-existing thrombophilia. Maternal only: history of pre-eclampsia, over 10 years from last pregnancy, multiple partners, assisted reproductive technology (ART), oocyte or embryo donation, weight at term (Kg).

  Three months

Secondary Outcomes (2)

• Maternal outcomes measured by a novel multiple choice on-line questionnaire

  Three months

• Fetal outcomes measured by a novel multiple choice on-line questionnaire

  Three months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Asst Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Chiara Viviani, M.D.

  ASST Papa Giovanni XXIII, Bergamo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: December 5, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

IT (1)