Streptococcus B Carrier State Complicating PregnancyGBSNCT02528890
Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
An observational study of Streptococcus B Carrier State Complicating Pregnancy, run by The Nazareth Hospital, Israel at 1 site in Israel.
Trial summary
The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Streptococcus B Carrier State Complicating Pregnancy
- What is being tested?
- vaginal/anal swab for GBS from all participants
- How many people
- 196 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Mar 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will include 184 participants who meet the inclusion criteria and gave their informed consent to participate. The sample size enables a confidence level of 95% within a 5% range of the GBS carrier rate, assuming that the rate is close to 17%. The investigators assume to identify 23 to 41 carriers, which will allow comparison of demographic variables between carriers and non-carriers.
Who may be able to join
- Age: 18 to 40
- Origin: Arab
- Gestational age: 34 to 40
Who cannot join
- Rupture of membranes
- Women in active labor who has had one or more vaginal examinations.
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in any of the high-risk groups that need to have prophylactic antibiotic treatment before delivery. Therefore, the question was whether pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than the general rate in Israel?
Read the detailed description
Signs of early onset GBS infection of the newborn appear during the first week of life. Usually, the bacteria pass from a GBS carrier mother to the newborn during labor. The infection can cause multi-system problems such as pneumonia, meningitis and even death of the newborn. The prevention of the disease is best achieved by prophylactic antibiotics administered to the mother during labor.
In order to prevent early onset GBS infection of the newborn, pregnant women are treated with preventive antibiotics during labor based on either of two protocols:
- Risk factors: Women with risk factors such as premature birth, prolonged premature rupture of membranes, intra-partum maternal fever or a previous child with GBS infection are treated.
- Universal screening: Towards the end of pregnancy, at 35 - 37th week, a vaginal/anal swab for GBS is taken, and those found positive will be treated.
According to the Israeli Ministry of Health regulations' from July 2005 it is not accepted to routinely perform screening for GBS in pregnant women at 35-37th week of pregnancy. Therefore, the Israeli approach to prevent early neonatal GBS infection is based mainly on antibiotic prophylaxis treatment during labor of all pregnant women with risk factors.
In a study conducted at the Western Galilee Medical Center in the city of Nahariya and published in 2006, there was a significant increase in the GBS carrier state rate compared to previously published studies. It was also found that higher GBS carrier state rates prevail among Arab women compared to Jewish women.
The primary question of this study is to calculate GBS carrier state prevalence among pregnant Arab women attending the labor ward at the Nazareth Hospital at the 34 to 40th week of their pregnancy.
A vaginal / anal swab will be taken from all eligible participants to identify GBS carriers by PCR (polymerase chain reaction) test.
- Being tested
- vaginal/anal swab for GBS from all participants
- Keywords
- group B streptococcus, GBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal/anal swab for GBS from all participantsOther
All eligible pregnant women, who meet the inclusion criteria and gave their informed consent to participate in the study has to complete a questionnaire and have a vaginal / anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test.
| Study group | Role | What they receive |
|---|---|---|
| preganat women between 34 - 40 weeks | Eligible pregnant women, who meet the inclusion criteria, will have a vaginal/anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test. Receives: Other: vaginal/anal swab for GBS from all participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of participants with positive GBS swab
GBS swab results are: "+" = positive, which means the participant is a carrier for GBS or "-" = negative, which means the participant is not a carrier for GBS
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus B Carrier State Complicating PregnancyStudies 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Nazareth Hospital, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Hakim, The Nazareth Hospital, Israel
- Investigators
- Marwan M Hakim, MD, DSc, Principal investigator, Nazareth Hospital EMMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528890
- Sponsor's protocol ID
- 15-2015
- Acronym
- GBS
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
- ClinicalTrials.gov ID
- NCT02528890
- Acronym / sponsor ID
- GBS / 15-2015
- Keywords
- group B streptococcus, GBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- The Nazareth Hospital, IsraelUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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 incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in any of the high-risk groups that need to have prophylactic antibiotic treatment before delivery. Therefore, the question was whether pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than the general rate in Israel?
Detailed description
Signs of early onset GBS infection of the newborn appear during the first week of life. Usually, the bacteria pass from a GBS carrier mother to the newborn during labor. The infection can cause multi-system problems such as pneumonia, meningitis and even death of the newborn. The prevention of the disease is best achieved by prophylactic antibiotics administered to the mother during labor.
In order to prevent early onset GBS infection of the newborn, pregnant women are treated with preventive antibiotics during labor based on either of two protocols:
- Risk factors: Women with risk factors such as premature birth, prolonged premature rupture of membranes, intra-partum maternal fever or a previous child with GBS infection are treated.
- Universal screening: Towards the end of pregnancy, at 35 - 37th week, a vaginal/anal swab for GBS is taken, and those found positive will be treated.
According to the Israeli Ministry of Health regulations' from July 2005 it is not accepted to routinely perform screening for GBS in pregnant women at 35-37th week of pregnancy. Therefore, the Israeli approach to prevent early neonatal GBS infection is based mainly on antibiotic prophylaxis treatment during labor of all pregnant women with risk factors.
In a study conducted at the Western Galilee Medical Center in the city of Nahariya and published in 2006, there was a significant increase in the GBS carrier state rate compared to previously published studies. It was also found that higher GBS carrier state rates prevail among Arab women compared to Jewish women.
The primary question of this study is to calculate GBS carrier state prevalence among pregnant Arab women attending the labor ward at the Nazareth Hospital at the 34 to 40th week of their pregnancy.
A vaginal / anal swab will be taken from all eligible participants to identify GBS carriers by PCR (polymerase chain reaction) test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preganat women between 34 - 40 weeks | – | Other: vaginal/anal swab for GBS from all participantsEligible pregnant women, who meet the inclusion criteria, will have a vaginal/anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include 184 participants who meet the inclusion criteria and gave their informed consent to participate. The sample size enables a confidence level of 95% within a 5% range of the GBS carrier rate, assuming that the rate is close to 17%. The investigators assume to identify 23 to 41 carriers, which will allow comparison of demographic variables between carriers and non-carriers.
Key inclusion criteria (3 listed)
- Age: 18 to 40
- Origin: Arab
- Gestational age: 34 to 40
Key exclusion criteria (2 listed)
- Rupture of membranes
- Women in active labor who has had one or more vaginal examinations.
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 |
|---|---|---|
| vaginal/anal swab for GBS from all participantsAll eligible pregnant women, who meet the inclusion criteria and gave their informed consent to participate in the study has to complete a questionnaire and have a vaginal / anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test. | Other | preganat women between 34 - 40 weeks |
Primary outcome
percentage of participants with positive GBS swab
Time frame: one year
GBS swab results are: "+" = positive, which means the participant is a carrier for GBS or "-" = negative, which means the participant is not a carrier for GBS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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.
Marwan M Hakim, MD, DSc principal investigator
Nazareth Hospital EMMS
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 Streptococcus B Carrier State Complicating Pregnancy, run by The Nazareth Hospital, Israel 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with positive GBS swab (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2016.