Extended-spectrum β-lactamase -Producing Enterobacteriaceae (ESBL) Vertical Transmission in Women With Preterm Labor Versus Those in Term Pregnancy
Extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL) Vertical Carriage and Transmission Rates in Women With Preterm Labor Versus Women With Term Pregnancy
1 other identifier
observational
300
1 country
1
Brief Summary
The aims of the study are to evaluate the rate of ESBL-producing Enterobacteriaceae colonization among women in preterm labor and term labor, the incidence of maternal vertical transmission of ESBL, and the clinical significance of ESBL in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2017
CompletedFirst Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMarch 8, 2021
March 1, 2021
4.6 years
August 14, 2017
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal rectal and vaginal specimens will be compared to assess influence of culturing site and admission and labor specimens will be compared for possible influence of hospitalization on ESBL carriage
positive ESBL vs. negative ESBL
two years
Study Arms (2)
women with preterm labor
pregnant women \< 37 weeks of gestations with regular uterine contractions and \> 3 cm dilation, \> 80% effacement
women with term pregnancy
pregnant women \> 37 weeks of gestation
Interventions
Two swabs will be taken at each screen: one from the vagina and the other from the rectum for vaginal and rectal assessment of maternal colonization
Eligibility Criteria
women in preterm labor women in term labor
You may qualify if:
- Preterm delivery \<37 weeks of gestation
- term delivery \> 37 weeks of gestation
You may not qualify if:
- Unknown gestational age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Galil Medical Center
Nahariya, Israel
Related Publications (1)
Sgayer I, Glikman D, Shqara RA, Maimon M, Rechnitzer H, Lowenstein L, Wolf MF. Maternal colonization with extended-spectrum beta-lactamase-producing Enterobacteriaceae in term versus preterm pregnancies. Int J Gynaecol Obstet. 2023 May;161(2):447-454. doi: 10.1002/ijgo.14555. Epub 2022 Nov 22.
PMID: 36334053DERIVED
Biospecimen
Two swabs will be taken at each screen: one from the vagina and the other from the rectum for vaginal and rectal assessment of maternal colonization. Maternal colonizing ESBL strain will be compared with infant's strain, if detected by the routine weekly NICU rectal surveillance for ESBL carriage.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maya Wolf, MD
Galilee Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 16, 2017
Study Start
April 12, 2017
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
March 8, 2021
Record last verified: 2021-03