Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor

NCT02511444 | Completed

• 1 other identifier: 534-15
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Group B Streptococcus

Keywords

GBS; GBS culture; GBS PCR; GBS colonization

Outcome Measures

Primary Outcomes (4)

• Sensitivity of intrapartum GBS real time PCR compared to intrapartum GBS culture

  up to one and a half year

• Positive predictive value of GBS Real time PCR performed intrapartum

  up to one and a half year

• Negative predictive value of GBS real time PCR performed intrapartum

  up to one and a half year

• Specificity of intrapartum GBS real time PCR compared to intrapartum GBS

  up to one and a half year

Secondary Outcomes (11)

• Neonatal GBS septicemia

  up to one and a half year

• Composite neonatal morbidity

  up to one and a half year

• number of neonatal intensive care unit days

  up to one and a half year

• Neonatal mortality rate

  up to one and a half year

• necrotizing enterocolitis

  up to one and a half year

Other Outcomes (7)

• Neonatal intraventricular hemorrhage

  up to one and half year

• Neonatal pneumonia

  up to one and half year

• Neonatal osteomyelitis

  up to one and half year

Study Arms (1)

single arm

OTHER

All patients will have GBS culture and real time PCR performed.

Other: GBS culture and real time PCR

Interventions

GBS culture and real time PCR OTHER

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.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Exposure to antibiotics within 1 week prior to enrollment (15)
• Known GBS bacteriuria at the time of enrollment
• Prior history of neonatal GBS sepsis

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Miller Children's & Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Related Publications (22)

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  PMID: 17904971 BACKGROUND

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  PMID: 15867030 BACKGROUND

• Young 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.

  PMID: 21864820 BACKGROUND

• Goins 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.

  PMID: 20502293 BACKGROUND

• Van 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.

  PMID: 19535801 BACKGROUND

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  PMID: 20860701 BACKGROUND

• Edwards 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.

  PMID: 18515517 BACKGROUND

• El 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.

  PMID: 19580414 BACKGROUND

• Convert M, Martinetti Lucchini G, Dolina M, Piffaretti JC. Comparison of LightCycler PCR and culture for detection of group B streptococci from vaginal swabs. Clin Microbiol Infect. 2005 Dec;11(12):1022-6. doi: 10.1111/j.1469-0691.2005.01275.x.

  PMID: 16307558 BACKGROUND

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• Goodrich JS, Miller MB. Comparison of culture and 2 real-time polymerase chain reaction assays to detect group B Streptococcus during antepartum screening. Diagn Microbiol Infect Dis. 2007 Sep;59(1):17-22. doi: 10.1016/j.diagmicrobio.2007.03.023. Epub 2007 May 16.

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• Mueller M, Henle A, Droz S, Kind AB, Rohner S, Baumann M, Surbek D. Intrapartum detection of Group B streptococci colonization by rapid PCR-test on labor ward. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:137-41. doi: 10.1016/j.ejogrb.2014.02.039. Epub 2014 Mar 12.

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• El Helali N, Giovangrandi Y, Guyot K, Chevet K, Gutmann L, Durand-Zaleski I. Cost and effectiveness of intrapartum group B streptococcus polymerase chain reaction screening for term deliveries. Obstet Gynecol. 2012 Apr;119(4):822-9. doi: 10.1097/AOG.0b013e31824b1461.

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• Wernecke M, Mullen C, Sharma V, Morrison J, Barry T, Maher M, Smith T. Evaluation of a novel real-time PCR test based on the ssrA gene for the identification of group B streptococci in vaginal swabs. BMC Infect Dis. 2009 Sep 4;9:148. doi: 10.1186/1471-2334-9-148.

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MeSH Terms

Interventions

Real-Time Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Alex Fong, MD

  Maternal Fetal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2019
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)