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Antibiotic

Antibiotics for Vaginal Laceration (ASPIRe Trial)

Phase 4

Recruiting

Led By Christina Lewicky-Gaupp, M.D

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Administered Ancef during wound repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ASPIRe Trial Summary

This trial is testing whether 5 days of oral antibiotics after suffering a severe vaginal laceration can prevent wound infection and accidental bowel leakage.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests if a five-day course of oral antibiotics (Augmentin/Flagyl or Augmentin/Clindamycin) versus placebo can prevent infection in severe perineal lacerations post-childbirth. Participants will also receive standard IV antibiotics and undergo intensive follow-up for healing and symptoms assessment.See study design

What are the potential side effects?

Potential side effects from the antibiotics may include digestive issues such as nausea or diarrhea, allergic reactions, yeast infections due to altered flora balance, and rarely more serious effects like antibiotic resistance.

ASPIRe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a severe tear during vaginal delivery at Prentice Women's Hospital.

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I received Ancef for wound healing.

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I am 18 years old or older.

ASPIRe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

This study has one endpoint which will be the 3-month postpartum visit and where all study participants will have completed their study questionnaires.

ASPIRe Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Antibiotic GroupExperimental Treatment1 Intervention

The antibiotic regimen chosen is based on the Royal College of Obstetricians and Gynecologists' recommendations (Augmentin and Flagyl or Clindamycin and Flagyl if they are allergic to Penicillin). The dosage for the antibiotics are the following: Flagyl 500mg po BID (twice a day) X 5 days, Clindamycin 400 mg po TID (three times a day) X 5 days, Augmentin 875mg po BID X 5 days.

Group II: Placebo GroupPlacebo Group1 Intervention

Women randomized not to receive antibiotics will be given placebo tablets postpartum, so they will all have an identical experience to the women in the experimental (antibiotic) group.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

916,957 Total Patients Enrolled

Christina Lewicky-Gaupp, M.D2.04 ReviewsPrincipal Investigator - Northwestern Medicine

Northwestern University

1Patient Review

After my consultation with Dr. Lewicky, I had an uneasy feeling. I'm glad I followed my instincts and sought a second opinion. I was shocked to discover that the recommendations Dr. Lewicky made were not only unnecessary, but could have potentially caused more problems. It's clear that she is not up-to-date on the latest procedures and treatments, and does not have the best interests of her patients at heart. I would not recommend her to anyone.

Oluwateniola Brown, M.DPrincipal InvestigatorNorthwestern Medicine

Media Library

Augmentin/Flagyl or Augmentin/Clindamycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04573504 — Phase 4

Vaginal Laceration Clinical Trial 2023: Augmentin/Flagyl or Augmentin/Clindamycin Highlights & Side Effects. Trial Name: NCT04573504 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently undergoing treatment as part of this clinical experiment?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial is presently seeking candidates with the study first being posted on September 23rd 2020 and most recently updated November 2nd 2021. A total of 274 patients are required at 1 site in order for recruitment efforts to be successful."

Answered by AI

What clinical conditions are regularly treated with Augmentin/Flagyl or Augmentin/Clindamycin?

"Cysto-urethritis often responds well to antibiotic treatment with a combination of Augmentin and Flagyl or Clindamycin. This dual therapy is also used for treating bacterial endocarditis, lower respiratory tract infections (lrti), and anaerobic bacteria."

Answered by AI

What adverse effects may accompany the concurrent use of Augmentin and Flagyl/Clindamycin?

"The safety of the Augmentin/Flagyl or Augmentin/Clindamycin drug combination has been verified by a Phase 4 trial and received an assessment score of 3."

Answered by AI

Are there any vacancies for individuals to participate in this medical experiment?

"Clinicaltrials.gov indicates that patient recruitment is still occurring for this investigation, which was originally posted on September 23rd 2020 and revised most recently on November 2nd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Oluwateniola Brown 2020. "Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04573504.