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NCT04573504 · ClinicalTrials.gov registry record · Phase 4
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
A Phase 4 study of Vaginal Laceration During Delivery, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 274
- Enrollment target
- 1
- Study location
NCT04573504: Recruiting Phase 4 study of Vaginal Laceration During Delivery, sponsored by Northwestern University.
NCT04573504 is a Phase 4 study of Vaginal Laceration During Delivery that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 274 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04573504, a Phase 4 study of Vaginal Laceration During Delivery, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 274 participants
- Enrollment target
- 1
- Study location
Study Summary
Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and ultimately, accidental bowel leakage. Women who suffer a severe vaginal laceration will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. All women will have immediate, intensive follow-up with an Urogynecologist at our well-established PEAPOD peripartum clinic at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection. At these visits, we also will assess women's perception of their well-being, perineal pain, and bowel symptoms. All participants will be invited to remain in the study for long-term follow-up. Our goal is to establish whether a five-day course of oral antibiotics should be a standard part of clinical care for severe postpartum lacerations.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Augmentin/Flagyl or Augmentin/Clindamycin
Study Locations (1)
Illinois
- Prentice Women's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
What NCT04573504 shows while recruiting
NCT04573504 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Vaginal Laceration During Delivery appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04573504 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04573504 about?
NCT04573504 is a clinical study titled "Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair". Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and brea...
What is the current status of trial NCT04573504?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 274 participants. The study started on 2020-09-23. Estimated completion is 2024-12-31.
What conditions does trial NCT04573504 study?
This clinical trial studies the following conditions: Vaginal Laceration During Delivery.
What interventions are being tested in trial NCT04573504?
The interventions under investigation include: Placebo (DRUG), Augmentin/Flagyl or Augmentin/Clindamycin (DRUG).
Who is sponsoring clinical trial NCT04573504?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04573504 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vaginal Laceration During Delivery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04573504's enrollment target sits among peer trials
274 312th of 2000 higher than 1,687 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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