UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037012 |
|---|---|
| Receipt number | R000042168 |
| Scientific Title | Pre-pregnancy risk factors and development of preeclampsia: A population-based study |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/06/10 13:53:07 |
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Basic information
Public title
Pre-pregnancy risk factors and development of preeclampsia
Acronym
Reunion
Scientific Title
Pre-pregnancy risk factors and development of preeclampsia: A population-based study
Scientific Title:Acronym
Reunion
Region
| Africa |
Condition
Condition
Preeclampsia
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The recognition of different preeclampsia phenotypes, in particular differentiation between early onset preeclampsia (EOP) and late onset preeclampsia (LOP) has been of pivotal importance in our quest of comprehending the pathophysiology of this still enigmatic syndrome.Classical risk factors for preeclampsia may be summarized as: nulliparity, primipaternity, advanced maternal age, previous preeclampsia, high body mass index (BMI), gestational diabetes, multiple gestations, assisted reproduction and pre-existing medical conditions such as chronic hypertension, antiphospholipid antibody syndrome and renal disease.To assess the impact of each risk factor for the development of this syndrome as early and late onset disease.
Basic objectives2
Others
Basic objectives -Others
Pre-pregnancy risk factors for the development of preeclampsia later in pregnancy.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Developmento of preeclampsia
Key secondary outcomes
Identification of the main risk factors.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Singleton pregnancy, ongoing pregnancy
Key exclusion criteria
Twin pregnancy, miscarriage
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Pierre-Yves |
| Middle name | |
| Last name | Robillard |
Organization
Service de Neonatologie. Centre Hospitalier Universitaire Sud Reunion, BP 350, 97448 Saint-Pierre Cedex, La Reunion.
Division name
Service de Neonatologie
Zip code
97448
Address
BP 350, 97448 Saint-Pierre cedex
TEL
+262692702459
robillard.reunion@wanadoo.fr
Public contact
Name of contact person
| 1st name | Marco |
| Middle name | |
| Last name | Scioscia |
Organization
Policlinico of Abano Terme, Padua 35031 Abano Terme (PD). Italy.
Division name
Department of Obstetrics and Gynaecology
Zip code
35031
Address
Piazza Cristoforo Colombo 1
TEL
+393498724206
Homepage URL
marcoscioscia@gmail.com
Sponsor or person
Institute
Centre Hospitalier Universitaire Sud Reunion
Institute
Department
Personal name
Funding Source
Organization
Centre Hospitalier Universitaire Sud Reunion
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Comite de Protection des Personnes Sud-Ouest et Outre Mer III
Address
BP 350, 97448 Saint-Pierre cedex, La Reunion
Tel
+262692702459
pierre-yves.robillard@chu-reunion.fr
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University South Reunion Island
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From January 1st, 2001, to 31 December 2018, the hospital records of all women delivered at the maternity of the University South Reunion Island (ap. 4 300 births per year) will be abstracted in standardized fashion.
Management information
Registered date
| 2019 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042168
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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