NCT03975764

Brief Summary

We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Status
unknown

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

First Submitted

Initial submission to the registry

June 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

June 2, 2019

Last Update Submit

June 4, 2019

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (1)

  • Unique microbial fingerprint

    16S rRNA gene sequencing

    1 year

Study Arms (2)

Preterm birth

Delivery between 24-32 weeks of gestation

Diagnostic Test: Collection of fecal sample

Term delivery

Delivery between 37-41 weeks of gastation

Diagnostic Test: Collection of fecal sample

Interventions

Collection of fecal sampleDIAGNOSTIC_TEST

Analysis of fecal microbiome

Preterm birthTerm delivery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Woman after vaginal delivery

You may qualify if:

  • Woman after vaginal delivery of singleton

You may not qualify if:

  • Fetal abnormalities
  • Gestational diabetes
  • Hypertensive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal semple

Central Study Contacts

Ola Gutzeit, MD

CONTACT

+972-543088220stolpnikk@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 5, 2019

Study Start

October 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share