Antibiotics for Vaginal Laceration

(ASPIRe Trial)

Overseen By Amelia Joblin, M.S.

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Systemic steroids

Disqualifiers: Under 18, Non-English, Twins, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 5 days

274 Participants Needed

Trial Summary

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.

Research Team

Oluwateniola Brown, M.D

Principal Investigator

Northwestern Medicine

Eligibility Criteria

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

Term Delivery (i.e. at least 37 weeks gestation)

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

First Delivery

Exclusion Criteria

I am currently taking steroids in pill or injection form.

You are pregnant with more than one baby (twins or more).

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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

5 days

Immediate postpartum visit for IV antibiotics

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

3 months

3 visits (in-person) at 1 week, 2 weeks, and 3 months postpartum

Long-term follow-up

Participants are invited to remain in the study for long-term follow-up to assess maternal health outcomes

Treatment Details

Interventions

• Augmentin/Flagyl or Augmentin/Clindamycin

Trial Overview 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.

Participant Groups

Group I: Antibiotic Group Experimental Treatment 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+