Antibiotics for Vaginal Laceration
(ASPIRe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Oluwateniola Brown, M.D
Principal Investigator
Northwestern Medicine
Are You a Good Fit for This Trial?
This trial is for English-speaking women over 18 who have just given birth to a single baby at full term and experienced severe vaginal tearing. They must have received Ancef during repair and be delivering at Prentice Women's Hospital. It excludes those with certain medication allergies, on systemic steroids, non-English speakers, under 18, or having multiples like twins.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 5-day course of oral antibiotics or placebo postpartum following a standard one-time dose of IV antibiotics at the time of repair
Follow-up
Participants have intensive follow-up with an Urogynecologist at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection
Long-term follow-up
Participants are invited to remain in the study for long-term follow-up to assess maternal health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Augmentin/Flagyl or Augmentin/Clindamycin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor