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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

Must not have

Non-English speaking

Patient is taking systemic steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I am currently taking steroids in pill or injection form.

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I cannot take metronidazole, clindamycin, or amoxicillin due to health reasons.

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I am younger than 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,652 Previous Clinical Trials

961,241 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