NCT03618836

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

August 1, 2018

Last Update Submit

August 1, 2018

Conditions

Preterm Birth

Keywords

Bacterial vaginosisVaginal microbiotaMolecular methodsNext generation sequencing

Outcome Measures

Primary Outcomes (1)

  • Vaginal Microbiota pattern

    All microorganism potentially present in the vagina

    10 years

Secondary Outcomes (1)

  • Vaginal biological pattern

    10 years

Study Arms (2)

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

Microbiological and biological patterns on vaginal samplesOTHER

To compare the microbiological and biological patterns between groups

Cases. Preterm BirthsControls. Term Births

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of pregnant patients in the first trimester

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancies, medical interruptions of pregnancy and deaths in utero

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jeanne de Flandres, CHRU

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal samples with DNA of microorganisms

MeSH Terms

Conditions

Premature BirthVaginosis, Bacterial

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Study Officials

  • Damien Subtil, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 7, 2018

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2014

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)