Group B StreptococcusNCT02511444
Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor
A study testing GBS culture and real time PCR in people with Group B Streptococcus, run by MemorialCare Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the test characteristics of a rapid intrapartum real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the standard in preterm patients presenting with threatened preterm labor or with obstetric indications for preterm delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Group B Streptococcus
- What is being tested?
- GBS culture and real time PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2019
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Pregnant women presenting for unplanned obstetrical care at a participating clinical study site
- Gestational age between 21 6/7 and 36 6/7 weeks
- Subject has not participated in the study before
- Subject agrees to complete all aspects of the study and provide informed consent in accordance with applicable regulations
- Signs and/or symptoms suggestive of preterm labor, whereby the managing clinician suspects preterm labor
Show all 14Show fewer
- Uterine contractions (with or without pain)
- Intermittent lower abdominal pain, dull backache, pelvic pressure
- Vaginal bleeding during the second and third trimester
- Menstrual-like intestinal cramping (with or without diarrhea)
- Change in vaginal discharge (amount, color, or consistency)
- Vague sense of discomfort characterized as "not feeling right"
- Change in cervical exam (cervical dilation, effacement, or consistency)
- Signs and symptoms necessitating preterm delivery (i.e abruption, preeclampsia, hemolysis elevated liver enzymes, low platelet (HELLP) syndrome, ruptured membranes, chorioamnionitis, fetal indications)
Who cannot join
- Exposure to antibiotics within 1 week prior to enrollment (15)
- Known GBS bacteriuria at the time of enrollment
- Prior history of neonatal GBS sepsis
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
About this study
The purpose of this study is to evaluate the test characteristics of a rapid intrapartum real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the standard in preterm patients presenting with threatened preterm labor or with obstetric indications for preterm delivery.
Read the detailed description
Group B streptococcus (GBS) or Streptococcus agalactiae is a gram-positive bacterium that colonizes 10-40% of maternal gastrointestinal and urogenital tract sites. Maternal colonization remains the primary risk factor and the leading cause of early onset GBS disease in infants in the United States. Transmission of GBS to the neonate in early onset GBS cases occurs at the time of labor and delivery, with a transmission rate of 52.5% if no intrapartum antibiotics are used. Of those neonates, 1-2% term infants and 8% of preterm infants will develop early onset disease.
The Centers for Disease Control (CDC) recommends universal screening at 35-37 weeks via culture of the vagina and rectum. If this is performed ≤5 weeks before delivery, it has a sensitivity of 85% and a negative predictive value of 95-98%. There is a downside to screening remote from delivery however; vaginal GBS colonization fluctuates in the same woman over time, thus rendering possibly inaccurate GBS results. It has been reported that at least 10% of antenatal GBS negative women turned positive at the time of labor. This may suggest that screening at the time of delivery is a more accurate method of predicting actual GBS colonization status. In fact, a majority of neonatal GBS sepsis occurs in infants born to mothers with a negative antepartum screening culture.
Currently, a standard GBS culture may take up to 3 days to obtain results. A rapid diagnostic test has more recently been studied as a possible method of GBS screening - real-time polymerase chain reaction (RT-PCR). Prior studies of RT-PCR, specifically the Cepheid GeneXpert GBS assay used at Miller's Children's and Women's Hospital, have reported sensitivity from 85-98.5% and specificity of 96-99.6% using data from term gestations. The CDC currently permits the use of RT-PCR as a rapid screening test for those with unknown status at term.
Several reports demonstrate that RT-PCR is a rapid, more sensitive method than standard culture for determining the intrapartum GBS colonization status. Some studies have also demonstrated the ability of RT-PCR to identify patients who would otherwise be missed by traditional GBS culture. A study by Mueller et al demonstrated that out of 64 patients with positive RT-PCR results, 10 were actually negative on culture. A cost-effectiveness analysis has demonstrated that PCR intrapartum screening strategy is not any less cost-effective than traditional culture and confers a significant decrease in early onset GBS disease in term gestations.
Preterm infants suffer the highest rate of mortality from GBS infection, with up to 30% mortality in those < 33 weeks affected by GBS sepsis. Identifying GBS colonization is thus imperative in the 7-11% of all pregnancies affected by preterm labor, given that they will not have undergone universal screening yet (which typically occurs at 35-37 weeks). While the CDC recommends giving antibiotics to patients with unknown GBS status at substantial risk for preterm delivery, implementation of this recommendation is poor.
Advantages of the RT-PCR are that its results will come back much more rapidly than the standard culture and may assist in management of these critical patients, 75 min vs 3 days, respectively. Accurate screening for GBS in a rapid fashion, especially in preterm infants, where the risk of GBS infection is most serious, can potentially allow antibiotics to be used appropriately.
The investigators seek to evaluate the utility of RT-PCR for screening of GBS in women at risk of preterm labor with an unknown GBS status. The investigators also aim to identify the ability of RT-PCR to identify GBS colonization in patients who would have otherwise been missed by culture.
- Conditions
- Group B Streptococcus
- Being tested
- GBS culture and real time PCR
- Keywords
- GBS, GBS culture, GBS PCR, GBS colonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS culture and real time PCROther
patients with signs and symptoms of threatened preterm labor, or indications for preterm delivery will have GBS colonization screened by culture and real time PCR.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | All patients will have GBS culture and real time PCR performed. Receives: Other: GBS culture and real time PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of intrapartum GBS real time PCR compared to intrapartum GBS culture
Measured: up to one and a half year
Positive predictive value of GBS Real time PCR performed intrapartum
Measured: up to one and a half year
Negative predictive value of GBS real time PCR performed intrapartum
Measured: up to one and a half year
Specificity of intrapartum GBS real time PCR compared to intrapartum GBS
Measured: up to one and a half year
Secondary outcomes (11)
Neonatal GBS septicemia
Measured: up to one and a half year
Composite neonatal morbidity
Measured: up to one and a half year
number of neonatal intensive care unit days
Measured: up to one and a half year
Neonatal mortality rate
Measured: up to one and a half year
necrotizing enterocolitis
Measured: up to one and a half year
Gestational age at delivery
Measured: up to one and a half year
vaginal delivery
Measured: up to one and a half year
Postpartum hemorrhage
Measured: up to one and a half year
Maternal intrapartum chorioamnionitis
Measured: up to one and a half year
Maternal postpartum endometritis
Measured: up to one and a half year
Neonatal respiratory distress
Measured: up to one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Group B StreptococcusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Fong, MD, Principal investigator, Maternal Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511444
- Sponsor's protocol ID
- 534-15
- Status last verified
- Nov 2022
- First submitted
- 23 Jul 2015
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010. MMWR Recomm Rep. 2010 Nov 19;59(RR-10):1-36.
PubMed 21088663Phares CR, Lynfield R, Farley MM, Mohle-Boetani J, Harrison LH, Petit S, Craig AS, Schaffner W, Zansky SM, Gershman K, Stefonek KR, Albanese BA, Zell ER, Schuchat A, Schrag SJ; Active Bacterial Core surveillance/Emerging Infections Program Network. Epidemiology of invasive group B streptococcal disease in the United States, 1999-2005. JAMA. 2008 May 7;299(17):2056-65. doi: 10.1001/jama.299.17.2056.
PubMed 18460666Dillon HC Jr, Gray E, Pass MA, Gray BM. Anorectal and vaginal carriage of group B streptococci during pregnancy. J Infect Dis. 1982 Jun;145(6):794-9. doi: 10.1093/infdis/145.6.794.
PubMed 7045248Regan JA, Klebanoff MA, Nugent RP. The epidemiology of group B streptococcal colonization in pregnancy. Vaginal Infections and Prematurity Study Group. Obstet Gynecol. 1991 Apr;77(4):604-10.
PubMed 2002986Turrentine MA, Ramirez MM. Recurrence of group B streptococci colonization in subsequent pregnancy. Obstet Gynecol. 2008 Aug;112(2 Pt 1):259-64. doi: 10.1097/AOG.0b013e31817f5cb9.
PubMed 18669720Hickman ME, Rench MA, Ferrieri P, Baker CJ. Changing epidemiology of group B streptococcal colonization. Pediatrics. 1999 Aug;104(2 Pt 1):203-9. doi: 10.1542/peds.104.2.203.
PubMed 10428995Valkenburg-van den Berg AW, Sprij AJ, Oostvogel PM, Mutsaers JA, Renes WB, Rosendaal FR, Joep Dorr P. Prevalence of colonisation with group B Streptococci in pregnant women of a multi-ethnic population in The Netherlands. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):178-83. doi: 10.1016/j.ejogrb.2005.06.007. Epub 2005 Jul 18.
PubMed 16026920Gavino M, Wang E. A comparison of a new rapid real-time polymerase chain reaction system to traditional culture in determining group B streptococcus colonization. Am J Obstet Gynecol. 2007 Oct;197(4):388.e1-4. doi: 10.1016/j.ajog.2007.06.016.
PubMed 17904971Puopolo KM, Madoff LC, Eichenwald EC. Early-onset group B streptococcal disease in the era of maternal screening. Pediatrics. 2005 May;115(5):1240-6. doi: 10.1542/peds.2004-2275.
PubMed 15867030Young BC, Dodge LE, Gupta M, Rhee JS, Hacker MR. Evaluation of a rapid, real-time intrapartum group B streptococcus assay. Am J Obstet Gynecol. 2011 Oct;205(4):372.e1-6. doi: 10.1016/j.ajog.2011.06.087. Epub 2011 Jun 29.
PubMed 21864820Goins WP, Talbot TR, Schaffner W, Edwards KM, Craig AS, Schrag SJ, Van Dyke MK, Griffin MR. Adherence to perinatal group B streptococcal prevention guidelines. Obstet Gynecol. 2010 Jun;115(6):1217-1224. doi: 10.1097/AOG.0b013e3181dd916f.
PubMed 20502293Van Dyke MK, Phares CR, Lynfield R, Thomas AR, Arnold KE, Craig AS, Mohle-Boetani J, Gershman K, Schaffner W, Petit S, Zansky SM, Morin CA, Spina NL, Wymore K, Harrison LH, Shutt KA, Bareta J, Bulens SN, Zell ER, Schuchat A, Schrag SJ. Evaluation of universal antenatal screening for group B streptococcus. N Engl J Med. 2009 Jun 18;360(25):2626-36. doi: 10.1056/NEJMoa0806820.
PubMed 19535801de Tejada BM, Pfister RE, Renzi G, Francois P, Irion O, Boulvain M, Schrenzel J. Intrapartum Group B streptococcus detection by rapid polymerase chain reaction assay for the prevention of neonatal sepsis. Clin Microbiol Infect. 2011 Dec;17(12):1786-91. doi: 10.1111/j.1469-0691.2010.03378.x. Epub 2011 Apr 12.
PubMed 20860701Edwards RK, Novak-Weekley SM, Koty PP, Davis T, Leeds LJ, Jordan JA. Rapid group B streptococci screening using a real-time polymerase chain reaction assay. Obstet Gynecol. 2008 Jun;111(6):1335-41. doi: 10.1097/AOG.0b013e31817710ee.
PubMed 18515517El Helali N, Nguyen JC, Ly A, Giovangrandi Y, Trinquart L. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis. 2009 Aug 1;49(3):417-23. doi: 10.1086/600303.
PubMed 19580414
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT02511444
- Acronym / sponsor ID
- 534-15
- Conditions
- Group B Streptococcus
- Keywords
- GBS, GBS culture, GBS PCR, GBS colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jul 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 purpose of this study is to evaluate the test characteristics of a rapid intrapartum real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the standard in preterm patients presenting with threatened preterm labor or with obstetric indications for preterm delivery.
Detailed description
Group B streptococcus (GBS) or Streptococcus agalactiae is a gram-positive bacterium that colonizes 10-40% of maternal gastrointestinal and urogenital tract sites. Maternal colonization remains the primary risk factor and the leading cause of early onset GBS disease in infants in the United States. Transmission of GBS to the neonate in early onset GBS cases occurs at the time of labor and delivery, with a transmission rate of 52.5% if no intrapartum antibiotics are used. Of those neonates, 1-2% term infants and 8% of preterm infants will develop early onset disease.
The Centers for Disease Control (CDC) recommends universal screening at 35-37 weeks via culture of the vagina and rectum. If this is performed ≤5 weeks before delivery, it has a sensitivity of 85% and a negative predictive value of 95-98%. There is a downside to screening remote from delivery however; vaginal GBS colonization fluctuates in the same woman over time, thus rendering possibly inaccurate GBS results. It has been reported that at least 10% of antenatal GBS negative women turned positive at the time of labor. This may suggest that screening at the time of delivery is a more accurate method of predicting actual GBS colonization status. In fact, a majority of neonatal GBS sepsis occurs in infants born to mothers with a negative antepartum screening culture.
Currently, a standard GBS culture may take up to 3 days to obtain results. A rapid diagnostic test has more recently been studied as a possible method of GBS screening - real-time polymerase chain reaction (RT-PCR). Prior studies of RT-PCR, specifically the Cepheid GeneXpert GBS assay used at Miller's Children's and Women's Hospital, have reported sensitivity from 85-98.5% and specificity of 96-99.6% using data from term gestations. The CDC currently permits the use of RT-PCR as a rapid screening test for those with unknown status at term.
Several reports demonstrate that RT-PCR is a rapid, more sensitive method than standard culture for determining the intrapartum GBS colonization status. Some studies have also demonstrated the ability of RT-PCR to identify patients who would otherwise be missed by traditional GBS culture. A study by Mueller et al demonstrated that out of 64 patients with positive RT-PCR results, 10 were actually negative on culture. A cost-effectiveness analysis has demonstrated that PCR intrapartum screening strategy is not any less cost-effective than traditional culture and confers a significant decrease in early onset GBS disease in term gestations.
Preterm infants suffer the highest rate of mortality from GBS infection, with up to 30% mortality in those < 33 weeks affected by GBS sepsis. Identifying GBS colonization is thus imperative in the 7-11% of all pregnancies affected by preterm labor, given that they will not have undergone universal screening yet (which typically occurs at 35-37 weeks). While the CDC recommends giving antibiotics to patients with unknown GBS status at substantial risk for preterm delivery, implementation of this recommendation is poor.
Advantages of the RT-PCR are that its results will come back much more rapidly than the standard culture and may assist in management of these critical patients, 75 min vs 3 days, respectively. Accurate screening for GBS in a rapid fashion, especially in preterm infants, where the risk of GBS infection is most serious, can potentially allow antibiotics to be used appropriately.
The investigators seek to evaluate the utility of RT-PCR for screening of GBS in women at risk of preterm labor with an unknown GBS status. The investigators also aim to identify the ability of RT-PCR to identify GBS colonization in patients who would have otherwise been missed by culture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: GBS culture and real time PCRAll patients will have GBS culture and real time PCR performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years
- Pregnant women presenting for unplanned obstetrical care at a participating clinical study site
- Gestational age between 21 6/7 and 36 6/7 weeks
- Subject has not participated in the study before
- Subject agrees to complete all aspects of the study and provide informed consent in accordance with applicable regulations
Key exclusion criteria (3 listed)
- Exposure to antibiotics within 1 week prior to enrollment (15)
- Known GBS bacteriuria at the time of enrollment
- Prior history of neonatal GBS sepsis
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 |
|---|---|---|
| GBS culture and real time PCRpatients with signs and symptoms of threatened preterm labor, or indications for preterm delivery will have GBS colonization screened by culture and real time PCR. | Other | single arm |
Primary outcome
Sensitivity of intrapartum GBS real time PCR compared to intrapartum GBS culture
Time frame: up to one and a half year
Positive predictive value of GBS Real time PCR performed intrapartum
Time frame: up to one and a half year
Negative predictive value of GBS real time PCR performed intrapartum
Time frame: up to one and a half year
Specificity of intrapartum GBS real time PCR compared to intrapartum GBS
Time frame: up to one and a half year
11 secondary outcomes
Neonatal GBS septicemia
Time frame: up to one and a half year
Composite neonatal morbidity
Time frame: up to one and a half year
number of neonatal intensive care unit days
Time frame: up to one and a half year
Neonatal mortality rate
Time frame: up to one and a half year
necrotizing enterocolitis
Time frame: up to one and a half year
Gestational age at delivery
Time frame: up to one and a half year
vaginal delivery
Time frame: up to one and a half year
Postpartum hemorrhage
Time frame: up to one and a half year
Maternal intrapartum chorioamnionitis
Time frame: up to one and a half year
Maternal postpartum endometritis
Time frame: up to one and a half year
Neonatal respiratory distress
Time frame: up to one and half year
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 22 Nov 2022.
- Background: PubMed 21088663Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010. MMWR Recomm Rep. 2010 Nov 19;59(RR-10):1-36.
- Background: PubMed 18460666Phares CR, Lynfield R, Farley MM, Mohle-Boetani J, Harrison LH, Petit S, Craig AS, Schaffner W, Zansky SM, Gershman K, Stefonek KR, Albanese BA, Zell ER, Schuchat A, Schrag SJ; Active Bacterial Core surveillance/Emerging Infections Program Network. Epidemiology of invasive group B streptococcal disease in the United States, 1999-2005. JAMA. 2008 May 7;299(17):2056-65. doi: 10.1001/jama.299.17.2056.
- Background: PubMed 7045248Dillon HC Jr, Gray E, Pass MA, Gray BM. Anorectal and vaginal carriage of group B streptococci during pregnancy. J Infect Dis. 1982 Jun;145(6):794-9. doi: 10.1093/infdis/145.6.794.
- Background: PubMed 2002986Regan JA, Klebanoff MA, Nugent RP. The epidemiology of group B streptococcal colonization in pregnancy. Vaginal Infections and Prematurity Study Group. Obstet Gynecol. 1991 Apr;77(4):604-10.
- Background: PubMed 18669720Turrentine MA, Ramirez MM. Recurrence of group B streptococci colonization in subsequent pregnancy. Obstet Gynecol. 2008 Aug;112(2 Pt 1):259-64. doi: 10.1097/AOG.0b013e31817f5cb9.
- Background: PubMed 10428995Hickman ME, Rench MA, Ferrieri P, Baker CJ. Changing epidemiology of group B streptococcal colonization. Pediatrics. 1999 Aug;104(2 Pt 1):203-9. doi: 10.1542/peds.104.2.203.
- Background: PubMed 16026920Valkenburg-van den Berg AW, Sprij AJ, Oostvogel PM, Mutsaers JA, Renes WB, Rosendaal FR, Joep Dorr P. Prevalence of colonisation with group B Streptococci in pregnant women of a multi-ethnic population in The Netherlands. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):178-83. doi: 10.1016/j.ejogrb.2005.06.007. Epub 2005 Jul 18.
- Background: PubMed 17904971Gavino M, Wang E. A comparison of a new rapid real-time polymerase chain reaction system to traditional culture in determining group B streptococcus colonization. Am J Obstet Gynecol. 2007 Oct;197(4):388.e1-4. doi: 10.1016/j.ajog.2007.06.016.
- Background: PubMed 15867030Puopolo KM, Madoff LC, Eichenwald EC. Early-onset group B streptococcal disease in the era of maternal screening. Pediatrics. 2005 May;115(5):1240-6. doi: 10.1542/peds.2004-2275.
- Background: PubMed 21864820Young BC, Dodge LE, Gupta M, Rhee JS, Hacker MR. Evaluation of a rapid, real-time intrapartum group B streptococcus assay. Am J Obstet Gynecol. 2011 Oct;205(4):372.e1-6. doi: 10.1016/j.ajog.2011.06.087. Epub 2011 Jun 29.
- Background: PubMed 20502293Goins WP, Talbot TR, Schaffner W, Edwards KM, Craig AS, Schrag SJ, Van Dyke MK, Griffin MR. Adherence to perinatal group B streptococcal prevention guidelines. Obstet Gynecol. 2010 Jun;115(6):1217-1224. doi: 10.1097/AOG.0b013e3181dd916f.
- Background: PubMed 19535801Van Dyke MK, Phares CR, Lynfield R, Thomas AR, Arnold KE, Craig AS, Mohle-Boetani J, Gershman K, Schaffner W, Petit S, Zansky SM, Morin CA, Spina NL, Wymore K, Harrison LH, Shutt KA, Bareta J, Bulens SN, Zell ER, Schuchat A, Schrag SJ. Evaluation of universal antenatal screening for group B streptococcus. N Engl J Med. 2009 Jun 18;360(25):2626-36. doi: 10.1056/NEJMoa0806820.
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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.
Alex Fong, MD principal investigator
Maternal Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBS culture and real time PCR in people with Group B Streptococcus, run by MemorialCare Health System at 1 site in United States.
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 14 inclusion and 3 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 22 Nov 2022. 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 United States. 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?
Sensitivity of intrapartum GBS real time PCR compared to intrapartum GBS culture (time frame: up to one and a half year). The study lists 4 primary outcomes in all. 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 NCT02511444, which also lists 22 linked publications.
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 22 Nov 2022.