At a glance
ClinicalIndex Comparison RecordN/ACompleted· 288 enrolled
Drug / intervention
Sterile speculum exam +2 moreprocedure
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.
Analysis of ROM Plus to Detect Rupture of Membranes
In Brief
An observational study evaluating Sterile speculum exam, ROM Plus Exam, and 1 other intervention for Rupture of Amniotic Membranes. Completed, enrolled 288 participants across 1 site.
Detailed Summary
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRupture of Amniotic Membranes
CountriesUnited States
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedJun 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedJun 6, 2011
Enrollment StartSep 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago
Interventions
Sterile speculum examprocedure
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
ROM Plus Examprocedure
Vaginal swab exam for ROM Plus Test
Chart Reveiwprocedure
Post delivery blinded chart review by expereienced obstetrician