Overview

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Northwestern University
Treatments:
Amoxicillin-Potassium Clavulanate Combination
Clindamycin
Clindamycin palmitate
Clindamycin phosphate