Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

NCT04573504 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STU00212963
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Laceration During Delivery

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome measure will be at the 3 month postpartum visit where all study participants have complete all study procedures and surveys. We anticipate it will take two years for all participants to have met the time frame of completing their 3 month post-partum visit.

  2 years

Study Arms (2)

Antibiotic Group

EXPERIMENTAL

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.

Drug: Augmentin/Flagyl or Augmentin/Clindamycin

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Augmentin/Flagyl or Augmentin/Clindamycin DRUG

Women who suffer a severe vaginal laceration at Prentice Women's Hospital 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.

Antibiotic Group

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and older
• rd or 4th degree laceration upon delivering vaginally at Prentice Women's Hospital
• English-speaking
• Administered Ancef during wound repair
• First Delivery
• Single child being born
• Term Delivery (i.e. at least 37 weeks gestation)

You may not qualify if:

• Under 18 years old
• Non-English speaking
• Delivery of more than one fetus (i.e. twins or other multiples)
• Patient is taking systemic steroids
• Allergy to Amoxicillin AND Clindamycin
• Infant with severe jaundice who is receiving breastmilk
• Women who have medical contraindications to the use of metronidazole, clindamycin, and amoxicillin clavulanate.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Metronidazole

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Oluwateniola Brown, M.D

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Villegas, M.A.

CONTACT

312-503-1447; andrea.villegas@nm.org

Amelia Joblin, M.S.

CONTACT

312-695-7748; amelia.joblin@nm.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Northwestern University

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: September 23, 2020
• Primary Completion: September 23, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)