Clinical trial · Interventional
Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer
NCT02167438CI-TRIAL-00026556terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cesarean Section | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hem-Avert Perianal Stabilizer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Investigational
- description
- Application of the Hem-Avert device.
- interventionNames
- Device: Hem-Avert Perianal Stabilizer
- type
- NO_INTERVENTION
- label
- Control
- description
- No Application of the Hem-Avert device.
Primary outcomes (1)
- measure
- Measuring the reduction in Cesarean section rates.
- timeFrame
- 12 Months
- description
- This study is a single-site, prospective, randomized, concurrently-controlled study. Subjects will undergo screening to determine their enrollment eligibility. All subjects who meet inclusion criteria will be offered participation in this study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pregnant women between the ages of 18 and 40 years old at the time of enrollment 2. Gestational age between 34 and 42 weeks at the time of enrollment 3. Live singleton gestation 4. Candidate for vaginal delivery. 5. Willing and able to comply with the study plan as indicated by understanding and signing the subject informed consent form Exclusion Criteria: 1. Subject unable to speak English 2. Subject unable to understand and sign the informed consent form 3. Delivery planned outside the clinical center 4. Subject is scheduled for vaginal delivery with anticipated complications (i.e. including but not limited to non-vertex presentation or macrosomia \>4,000 grams) 5. Subject scheduled for an elective cesarean birth 6. Preeclampsia with severe features, eclampsia, HELLP syndrome 7. Multiple Gestation 8. PROM (premature rupture of membranes) 9. Previous Cesarean Section 10. PTL (preterm labor) 11. Known major fetal anomaly or fetal demise. 12. Suspected or proven chorioamnionitis 13. Placenta previa 14. Maternal insulin dependent diabetes 15. Maternal health conditions deemed as risk factors by investigators such as renal or cardiopulmonary disease
References
Publications (0)
Data not yet available
No reference posted for this study.