N/A
Completed N=288
Analysis of ROM Plus to Detect Rupture of Membranes
Rupture of Amniotic Membranes
Source: ClinicalTrials.gov NCT01366443 ↗
Enrolled (actual)
288
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus — 95; 88; 160; 187 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus |
95; 88; 160; 187; 2; 9 | — |
Eligibility Criteria
Exclusion Criteria
- Known placental previa
- Active vaginal bleeding
Data sourced from ClinicalTrials.gov (NCT01366443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.