Antibiotics for Vaginal Laceration
(ASPIRe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether taking oral antibiotics for five days after childbirth can prevent infections and aid healing in women with severe vaginal tears. The study compares women taking antibiotics (specifically Augmentin/Flagyl or Augmentin/Clindamycin) to those taking placebo pills to determine which group experiences better outcomes, such as fewer infections and reduced bowel leakage. Women who have had their first vaginal delivery, with a single baby, and experienced a severe tear may be suitable for this study. Participants will receive close follow-up care to monitor healing and overall well-being. The goal is to determine if antibiotics should routinely be part of care for these childbirth injuries. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking systemic steroids, you would not be eligible to participate.
What is the safety track record for these treatments?
Research has shown that antibiotics like Augmentin and Flagyl, or Augmentin and Clindamycin, can help prevent infections after childbirth-related tears. One study found that these antibiotics reduced the risk of wound infection by 6.6% compared to not using them.
These antibiotics are usually well-tolerated and considered safe, even during pregnancy. Most people do not experience serious side effects, though some may have mild stomach upset or diarrhea. It is important to discuss any concerns with a healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they offer a targeted antibiotic approach for vaginal lacerations, potentially improving recovery outcomes. Unlike the usual treatments, which might not specifically focus on infection prevention in this context, the combination of Augmentin with either Flagyl or Clindamycin is tailored to address the bacterial environment post-laceration, particularly for those allergic to Penicillin. This regimen is based on trusted recommendations from the Royal College of Obstetricians and Gynecologists, providing a structured, evidence-supported antibiotic course. By using specific antibiotics known for their efficacy in treating infections, these treatments could lead to faster and more effective healing, reducing complications and enhancing patient care.
What evidence suggests that this trial's treatments could be effective for severe postpartum lacerations?
In this trial, participants in the Antibiotic Group will receive either Augmentin and Flagyl or Augmentin and Clindamycin, following the Royal College of Obstetricians and Gynecologists' recommendations. Research has shown that these antibiotics can help prevent infections after severe vaginal tears during childbirth. Studies have found that they can lower the risk of wound problems after third- or fourth-degree tears. By stopping bacterial infections, antibiotics aid healing and reduce the chance of issues like bowel leakage. Reviews of multiple studies indicate that treatments with these antibiotics have high success rates, often between 70% and 82%, making them a strong option for preventing infection and aiding healing in these cases.12678
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