Recruiting

Antibiotics

Sponsor:

Northwestern University

Code:

NCT04573504

Conditions

Vaginal Laceration During Delivery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Augmentin/Flagyl or Augmentin/Clindamycin

Placebo

Study Details

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

Study ID

NCT04573504

Start date

Sep 23, 2020

Status verified date

Mar, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Sep 23, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

274 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Antibiotic Group

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.

placebo comparator: Placebo Group

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.

Interventions

Augmentin/Flagyl or Augmentin/Clindamycin

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.

Placebo

Placebo

Primary outcome measure

  • This study has one endpoint which will be the 3-month postpartum visit and where all study participants will have completed their study questionnaires. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Prentice Women's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Christina Lewicky-Gaupp, M.D

More Information

Sponsor

Northwestern University

Last update posted

Apr 2, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-04-02.