UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	marcoscioscia@gmail.com

Sponsor
Institute	Centre Hospitalier Universitaire Sud Reunion
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042168