Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
Launched by NORTHWESTERN UNIVERSITY · Oct 1, 2020
Trial Information
Current as of July 04, 2025
Recruiting
Keywords
ClinConnect Summary
**Summary of the Clinical Trial on Antibiotics for Severe Perineal Lacerations**
This clinical trial is studying whether giving women antibiotics after they experience severe vaginal tears during childbirth can help prevent infections and other complications. Many women face serious lacerations during delivery, which can lead to issues like infections, poor healing, and even accidental bowel leakage. In this study, women who have these severe tears will be randomly assigned to receive either a five-day course of oral antibiotics or placebo pills (which look like medication but have no active ingredients) after receiving an initial dose of IV antibiotics during their repair. The goal is to see if the additional antibiotics make a real difference in recovery.
To be eligible for this trial, women must be at least 18 years old, have experienced a third or fourth degree laceration during their delivery at Prentice Women’s Hospital, and be able to speak English. They should only be having their first child and must be delivering at term (after 37 weeks of pregnancy). Participants will have follow-up appointments with specialists at a dedicated clinic shortly after delivery to check on their healing and any symptoms they may experience, like pain or bowel issues. This study not only aims to improve care for women with severe lacerations but also invites participants to stay involved for long-term follow-up.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 18 years old and older
- • 3rd 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)
- Exclusion Criteria:
- • 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.
About Northwestern University
Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Trial Officials
Oluwateniola Brown, M.D
Principal Investigator
Northwestern Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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