Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
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.
Approximately 3,000,000 women have vaginal deliveries each year in the United States.

 Five percent, (i.e., 150,000) of these women will experience an obstetrical anal sphincter
 injury (OASIS). OASIS is associated with chronic pain and sexual dysfunction. Moreover, 25%
 of women with OASIS will suffer from chronic accidental bowel leakage. In other words, one
 new woman every 14 minutes experiences an injury that leads to uncontrollable leakage of
 stool and gas. This woman is not only a new mother, but she may also be a teacher, a
 construction worker, a nurse, a doctor, or an executive who will have to deal with this
 devastating and embarrassing condition for the rest of her life. At age 45, women suffer from
 accidental bowel leakage at a rate that is eight times higher than that of men of the same
 age (1).

 It is likely that accidental bowel leakage is related not only to the structural disruptions
 that occur with OASIS, but also from complications, such as infection and poor wound healing.
 Women who suffer OASIS are at high risk for infection and poor healing; this is not
 surprising given that these lacerations are repaired and then continue to heal in a
 contaminated field (near stool). Poor healing and infection in the setting of OASIS make
 accidental bowel leakage, chronic pain, and sexual dysfunction even more likely (2-6).
 Unfortunately, even those infections that are recognized early and treated can still cause
 accidental bowel leakage decades after childbirth (7-9).

 Despite the many women affected by OASIS and its debilitating ramifications through the arc
 of a woman's life, there is a lack of evidence-based best practice to guide treatment and
 follow-up when it does occur. Even though infection and poor healing compromise outcomes,
 there are limited data regarding best practice to prevent of these complications. The use of
 antibiotics at the time of OASIS repair has become common based on our division's previous
 studies (15-18). However, no studies have been done to determine whether oral antibiotics
 immediately postpartum can further decrease the incidence of short and long-term
 complications. The Royal College of Obstetricians and Gynecologists recommends the use of
 antibiotics after OASIS repair (10), however, the basis of this recommendation is founded
 only on expert opinion. On the other hand, the American College of Obstetricians and
 Gynecologists provides no recommendation with regard to whether antibiotics should be used in
 the postpartum time. At our institution, almost all women who sustain OASIS during vaginal
 delivery receive a single dose of IV antibiotics based on our previously published work at
 Prentice, however, that while many physicians chose to administer oral antibiotics based on
 expert opinions, it is unknown whether these provide any specific benefit - again as many
 physicians chose to administer antibiotics regardless of the evidence to date. Standard care
 postpartum both nationally and internationally is highly varied and likely based on physician
 training and preference (11).

 Therefore, there is a great need for a trial to determine whether the use of supplemental
 antibiotics for 5 days postpartum will decrease rates of perineal wound infection and
 breakdown and improve maternal health outcomes. Such a trial will guide best practice,
 enhance the care of women, and potentially reduce the debilitating consequences of OASIS.
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

 -  History of C. Difficile infection

 -  Infant with severe jaundice who is receiving breastmilk

 -  Women who have medical contraindications to the use of metronidazole, clindamycin, and
 amoxicillin clavulanate.