Using antibiotics to prevent infection after severe vaginal tears during childbirth
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
PHASE4 · Northwestern University · NCT04573504
This study is testing if a five-day course of oral antibiotics can help prevent infections in women who have severe vaginal tears during childbirth.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04573504 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a five-day course of oral antibiotics can prevent infection and complications in women who experience severe vaginal lacerations during delivery. Participants will be randomly assigned to receive either antibiotics or a placebo after receiving a standard IV antibiotic at the time of repair. Follow-up visits with a Urogynecologist will occur at one week, two weeks, and three months postpartum to monitor healing, infection, and overall well-being. The study aims to address the significant risks associated with obstetrical anal sphincter injuries, including chronic pain and accidental bowel leakage.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women aged 18 and older who experience a 3rd or 4th degree laceration during their first vaginal delivery.
Not a fit: Patients who are under 18, non-English speaking, or have multiple fetuses will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infection and improve recovery outcomes for women with severe vaginal lacerations.
How similar studies have performed: Other studies have shown promising results with antibiotic use in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- Prentice Women's Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Oluwateniola Brown, M.D — Northwestern Medicine
- Study coordinator: Andrea Villegas, M.A.
- Email: andrea.villegas@nm.org
- Phone: 312-503-1447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vaginal Laceration During Delivery