Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03251885 |
| Other study ID # |
0188-16-NHR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 12, 2017 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Western Galilee Hospital-Nahariya |
| Contact |
Maya Wolf, MD |
| Phone |
972--507887800 |
| Email |
mayaw[@]gmc.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
