At a glance
ClinicalIndex Comparison RecordN/ACompleted· 342 enrolled
Drug / intervention
GBS culture and real time PCRother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm Labor
In Brief
A clinical study evaluating GBS culture and real time PCR for Group B Streptococcus. Completed, enrolled 342 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcus
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionJun 2018
Study CompletionDec 2019
TodayJul 2026
First PostedJul 30, 2015
Enrollment StartJul 1, 2015
Primary CompletionJun 1, 2018
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.9 years ago
Interventions
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.