Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Description

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

Vaginal Laceration During Delivery

Study Overview

Study Details

Study overview

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.

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Condition
Vaginal Laceration During Delivery
Intervention / Treatment

-

Contacts and Locations

Chicago

Prentice Women's Hospital, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Oluwateniola Brown, M.D, PRINCIPAL_INVESTIGATOR, Northwestern Medicine

Study Record Dates

2024-12-31