Preeclampsia/EclampsiaNCT02982265
Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016
An observational study of Preeclampsia/Eclampsia, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preeclampsia/Eclampsia
- How many people
- 1,527 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2016to Jan 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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parents to give informed consent to the processing of personal data, with the understanding that the consent could be withdrawn at any time
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Preeclampsia/Eclampsia
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preeclampsia/eclampsia in Italy
Measured: 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).
Measured: Three months
Secondary outcomes (2)
Maternal outcomes measured by a novel multiple choice on-line questionnaire
gestational week at term; gestational diabetes (defined as fasting plasma glucose level over 126 mg/dl or a fasting glycemia over 92 mg/dl and a 1-hour glycemia over 180 mg/dl and a 2-hour glycemia over 153 mg/dL in the 75 g oral glucose tolerance test), 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/or kidney failure (defined by the abrupt loss of kidney function; a serum creatinine concentration above 0.8 mg/dL during pregnancy may indicate an underlying renal dysfunction) resolved after childbirth or within 3 months from delivery or over 3 months from delivery or current.
Measured: Three months
Fetal outcomes measured by a novel multiple choice on-line questionnaire
weight at birth (grams), blood group when tested, abortion
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia/EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,527 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Viviani, Papa Giovanni XXIII Hospital
- Investigators
- Chiara Viviani, M.D., Principal investigator, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982265
- Sponsor's protocol ID
- Reg. 2016/0161
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02982265
- Acronym / sponsor ID
- Reg. 2016/0161
- Conditions
- Preeclampsia/Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,527 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of preeclampsia/eclampsia in Italy
Time frame: Three months
Aggregation of predisposing factors to pre-eclampsia / eclampsia in Italy measured by a novel multiple choice on-line questionnaire
Time frame: Three months
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).
2 secondary outcomes
Maternal outcomes measured by a novel multiple choice on-line questionnaire
Time frame: Three months
Fetal outcomes measured by a novel multiple choice on-line questionnaire
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Viviani, M.D. principal investigator
A.O. Ospedale Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia/Eclampsia, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preeclampsia/eclampsia in Italy (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.