drugset / Trial / NCT04573504

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

NCT04573504

Phase 4 Unknown 274 enrolled Northwestern University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2020-09-23
Primary completion
2024-09-23
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 875 mg Oral
Subject Clindamycin Unknown 400 mg Oral
Subject Metronidazole Small molecule 500 mg Oral

Indications

No indication recorded.