Extended-spectrum β-lactamase -Producing Enterobacteriaceae (ESBL) Vertical Transmission in Women With Preterm Labor Versus Those in Term Pregnancy

NCT ID: NCT03251885

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2022-06-30

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.

Detailed Description

Preterm delivery occurs before 37 weeks of gestation. Worldwide the preterm birth rate is estimated to be about 11% and in Israel the preterm birth rate is approximately 7% (1, 2). Preterm birth is the leading direct cause of neonatal death (death in the first 28 days of life), and is responsible for 27% of neonatal deaths worldwide. Preterm births are divided to spontaneous, due to preterm labor or preterm premature rupture of membrane, or iatrogenic with labor induction due to maternal or fetal complications. The major risk factors for spontaneous preterm birth include previous preterm delivery, multiple gestation, uterine anomaly, systemic infection, history of cervical surgery and short cervical length. The clinical findings of true labor (contractions plus cervical changes) are the same whether labor occurs preterm or at term (3).

Treatment of women <34 weeks of gestation with suspected preterm labor consist of a course of betamethasone to reduce neonatal morbidity and mortality associated with preterm birth, tocolytic drugs for up to 48 hours to delay delivery, antibiotics for Group B Streptococcus (GBS) chemoprophylaxis and magnesium sulfate for pregnancies at 24 to 32 weeks of gestation to provide neuroprotection against cerebral palsy and other types of severe motor dysfunction (4). A 2014 Cochrane review of randomized trials of intrapartum antibiotic treatment of women colonized with GBS found that intrapartum antibiotic prophylaxis resulted in a significant reduction in early-onset neonatal GBS infection and a non-significant reduction in neonatal mortality (5). Intrapartum antibiotic prophylaxis is given in cases of positive screening culture for GBS from either vagina or rectum, positive history of birth of an infant with early-onset GBS disease or GBS bacteriuria during the current pregnancy (6, 7, 8). Other risk factors of developing early-onset sepsis include Intrapartum fever ≥38ºC, preterm labor (<37 weeks of gestation) and prolonged rupture of membranes (≥18 hours); women who have these risk factors should receive antibiotic prophylaxis in labor (9).

The Israeli Center for Disease Control report concerning early-onset neonatal invasive GBS disease showed a relatively similar incidence of invasive disease over the years 2006-2015 (10). In contrast, a recent report showed a marked increase in Gram-negative early-onset sepsis. The incidence of early-onset Gram-negative sepsis in Israel during the years 2008-2014 was 0.49 for 1000 live births and increased from 0.16 per 1000 in 2008 to 0.32 in 2014 (11). The incidence of E.coli early-neonatal sepsis rises significantly in preterm births (55 in preterm births vs. 26 in term) and in 2014 the burden of disease caused by E.coli was higher than GBS.

Most Gram-negative pathogens are resistant to ampicillin. Resistance of isolated E.coli to second and third generation cephalosporins was noted in 8.3% of early-onset infections, particularly in preterm and low-birth weight neonates and imply transmission of resistant strains during labor. Extended-spectrum β- lactamase-producing Enterobacteriaceae (ESBL) are pathogens which are practically resistant to all penicillins and cephalosporines. ESBL- producing Enterobacteriaceae may also harbor additional antibiotic-resistant genes against aminoglycosides, trimethoprim-sulfamethoxazole, ciprofloxacin and other agents (12). Although the prevalence of ESBL carriage is unknown, it is clearly increasing in the community and in many parts of the world 10-40% of strains of E.coli and Klebsiella pneumoniae express ESBL. However, there are no guidelines concerning surveillance cultures of pregnant women both in term or preterm labor for ESBL colonization although neonatal screening in neonatal intensive care units (NICU), on admission and periodically after, is accepted in order to prevent ESBL transmission in the NICU. In addition, we would like to compare the rate of ESBL carriage rate in women in preterm versus term labor.

Conditions

Preterm Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

women with preterm labor

pregnant women \< 37 weeks of gestations with regular uterine contractions and \> 3 cm dilation, \> 80% effacement

swabs

Intervention Type: OTHER

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

women with term pregnancy

pregnant women \> 37 weeks of gestation

swabs

Intervention Type: OTHER

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

Interventions

swabs

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Preterm delivery <37 weeks of gestation
• term delivery > 37 weeks of gestation

Exclusion Criteria

• Unknown gestational age

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Maya Wolf

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Galilee Medical Center

Locations

Galil Medical Center

Nahariya, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Maya Wolf, MD

Role: CONTACT

mayaw@gmc.gov.il

972--507887800

Facility Contacts

Maya Wolf, MD

Role: primary

homesickid@yahoo.com

972-507887800

References

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.

Reference Type: DERIVED

PMID: 36334053 (View on PubMed)

Other Identifiers

0188-16-NHR

Identifier Type: -

Identifier Source: org_study_id