RECRUITING

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

Quick Facts

Study Start:2020-09-23
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04573504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years old and older
  2. * 3rd or 4th degree laceration upon delivering vaginally at Prentice Women's Hospital
  3. * English-speaking
  4. * Administered Ancef during wound repair
  5. * First Delivery
  6. * Single child being born
  7. * Term Delivery (i.e. at least 37 weeks gestation)
  1. * Under 18 years old
  2. * Non-English speaking
  3. * Delivery of more than one fetus (i.e. twins or other multiples)
  4. * Patient is taking systemic steroids
  5. * Allergy to Amoxicillin AND Clindamycin
  6. * Infant with severe jaundice who is receiving breastmilk
  7. * Women who have medical contraindications to the use of metronidazole, clindamycin, and amoxicillin clavulanate.

Contacts and Locations

Study Contact

Andrea Villegas, M.A.
CONTACT
312-503-1447
andrea.villegas@nm.org
Amelia Joblin, M.S.
CONTACT
312-695-7748
amelia.joblin@nm.org

Principal Investigator

Oluwateniola Brown, M.D
PRINCIPAL_INVESTIGATOR
Northwestern Medicine

Study Locations (Sites)

Prentice Women's Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Oluwateniola Brown, M.D, PRINCIPAL_INVESTIGATOR, Northwestern Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-23
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-09-23
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Vaginal Laceration During Delivery