Preterm LaborNCT03251885
Extended-spectrum β-lactamase -Producing Enterobacteriaceae (ESBL) Vertical Transmission in Women With Preterm Labor Versus Those in Term Pregnancy
An observational study of Preterm Labor, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- swabs
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Apr 2017to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women in preterm labor women in term labor
Who may be able to join
- Preterm delivery <37 weeks of gestation
- term delivery > 37 weeks of gestation
Who cannot join
- Unknown gestational age
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Galil Medical Center
Nahariya
Maya Wolf, MD, 972-507887800, homesickid@yahoo.com
About this study
Official title: Extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL) Vertical Carriage and Transmission Rates in Women With Preterm Labor Versus Women With Term Pregnancy
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.
Read the 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
- Being tested
- swabs
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swabsOther
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
| Study group | Role | What they receive |
|---|---|---|
| women with preterm labor | pregnant women < 37 weeks of gestations with regular uterine contractions and > 3 cm dilation, > 80% effacement Receives: Other: swabs | |
| women with term pregnancy | pregnant women > 37 weeks of gestation Receives: Other: swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start12 Apr 2017
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
- Investigators
- Maya Wolf, MD, Principal investigator, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251885
- Sponsor's protocol ID
- 0188-16-NHR
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36334053
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL) Vertical Carriage and Transmission Rates in Women With Preterm Labor Versus Women With Term Pregnancy
- ClinicalTrials.gov ID
- NCT03251885
- Acronym / sponsor ID
- 0188-16-NHR
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with preterm labor | – | Other: swabspregnant women < 37 weeks of gestations with regular uterine contractions and > 3 cm dilation, > 80% effacement |
| women with term pregnancy | – | Other: swabspregnant women > 37 weeks of gestation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women in preterm labor women in term labor
Key inclusion criteria (2 listed)
- Preterm delivery <37 weeks of gestation
- term delivery > 37 weeks of gestation
Key exclusion criteria (1 listed)
- Unknown gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swabsTwo 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 | Other | women with preterm labor, women with term pregnancy |
Primary outcome
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
Time frame: two years
positive ESBL vs. negative ESBL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 36334053Sgayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Wolf, MD principal investigator
Galilee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Wolf, MD (972--507887800, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.