NCT03253016

Brief Summary

A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal progesterone and maternal vaginal microbiome distribution during pregnancy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 26, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

August 14, 2017

Last Update Submit

August 14, 2017

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • vaginal microbiome distribution between the arms

    5 years

Study Arms (3)

cervicall cerclage

EXPERIMENTAL

to test vaginal microbiome distribution in women with cervical cerclage due to cervical incompetence in weeks: 12 14 18 26 32

Diagnostic Test: vaginal swab -microbiome test and blood test for cytokines

vaginal progesterone

EXPERIMENTAL

to test vaginal microbiome distribution in women treated with vaginal progesterone due to cervical shortening in weeks: 12 14 18 26 32

Diagnostic Test: vaginal swab -microbiome test and blood test for cytokines

contol

NO INTERVENTION

to test vaginal microbiome during pregnancies without cerclage or progesterone

Interventions

vaginal swab -microbiome test and blood test for cytokinesDIAGNOSTIC_TEST

vaginal microbiome test and blood test for cytokines repeated during pregnancy in the 3 arms

cervicall cerclagevaginal progesterone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • G- roup 1 - Pregnant women with a singleton gestation and cervical cerclage at 12-14 weeks of gestation due to obstetrical history characteristic of cervical insufficiency G- roup 2 - Pregnant women with a singleton gestation at 12-14 weeks of gestation without a history of cervical insufficiency
  • Group 3 - Pregnant women treated with progesterone due to previous preterm labor without cerclage

You may not qualify if:

  • A- cute cervical insufficiency P- roven or suspected chorioamnionitis P- remature rupture of membranes F- etal structural abnormality G- estation beyond 15 weeks A- ntibiotic usage in the past month P- robiotic use in the past month R- eported autoimmune disease or immunosuppressive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galil Medical Center

Nahariya, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Maya Wolf, MD

    Western Galilee Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Wolf, MD

CONTACT

972-507887800Mayaf@gmc.gov.il

Maya Wolf, MD

CONTACT

972-507887800homesickid@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 17, 2017

Study Start

March 26, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

August 17, 2017

Record last verified: 2017-03

Locations

IL(1)