Study of the Risk of PREMaturité According to the Balance... | NCT03618836

Studies
Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale

NCT03618836

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Aug 7, 2018Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Preterm Birth

Interventions

Microbiological and biological patterns on vaginal samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A01254-37	Other Identifier	ID-RCB number, ANSM
PHRC_N 2011N°19-22	Other Identifier	PHRC number

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 1, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 7, 2018Actual

Name	Class
Ministry of Health, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective

To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

Detailed Description

Material and methods Case-control study nested in a cohort of pregnant patients in the first trimester. Inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. The "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center.

Multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. Regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods.

Expected results

Patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. The parameters related to the risk of spontaneous prematurity at the p <0.20 threshold will then be analyzed by multi-level logistic regression.

Implications At a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases. Preterm Births		Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among spontaneous preterm births between 22 and 36 weeks	Other: Microbiological and biological patterns on vaginal samples
Controls. Term Births		Microbiological and biological patterns on vaginal samples in the first trimester of pregnancy among deliveries over ≥ 37 weeks	Other: Microbiological and biological patterns on vaginal samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microbiological and biological patterns on vaginal samples	Other	To compare the microbiological and biological patterns between groups	Cases. Preterm Births Controls. Term Births

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal Microbiota pattern	All microorganism potentially present in the vagina	10 years

Secondary Outcomes

Measure	Description	Time Frame
Vaginal biological pattern	Biochemical and immunological compounds present in the vagina	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers
controls : the following delivery over ≥ 37 weeks in the same center

Exclusion Criteria:

Multiple pregnancies, medical interruptions of pregnancy and deaths in utero

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cohort of pregnant patients in the first trimester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Damien Subtil, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Jeanne de Flandres, CHRU		Lille			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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