Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Amoxicillin-Potassium Clavulanate Combination; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• 18 years old and older

• 3rd or 4th degree laceration upon delivering vaginally at Prentice Women's Hospital

• English-speaking

• Administered Ancef during wound repair

• First Delivery

• Single child being born

• Term Delivery (i.e. at least 37 weeks gestation)

Exclusion Criteria:

• Under 18 years old

• Non-English speaking

• Delivery of more than one fetus (i.e. twins or other multiples)

• Patient is taking systemic steroids

• Allergy to Amoxicillin AND Clindamycin

• Infant with severe jaundice who is receiving breastmilk

• Women who have medical contraindications to the use of metronidazole, clindamycin, and amoxicillin clavulanate.