Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis

Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery.
A study staff member will describe the study and offer participation. If a patient agrees to
participate, she will sign research protocol and HIPAA consent forms and receive a copy of
these forms. The patient's chart will be flagged, indicating that she is a study participant.
The patient's prenatal care and labor and delivery will be managed by her physician per
standard of care at the physician's discretion, including routine intrapartum treatment of
Group B streptococcus (GBS) colonization using ampicillin. When a participating patient is
diagnosed with chorioamnionitis, she will be randomized in a blinded fashion to Arm 1
(Unasyn) or Arm 2 (ampicillin/gentamicin). She will be treated as per standard of care with
tylenol, intravenous fluids, and her labor managed per physician discretion. From the time of
diagnosis of chorioamnionitis until determination of treatment success or failure in the
postpartum period, the patient will receive intravenous antibiotics per the protocol arm to
which they have been assigned. If a patient has already been receiving ampicillin for GBS,
the ampicillin will be discontinued when the study drugs are initiated. In arm 1, the study
drugs will consist of Unasyn 3 grams intravenously every 6 hours, plus intravenous normal
saline placebo dose every 8 hours. In arm 2, the study drugs will consist of gentamicin
1.5mg/kg intravenously every 8 hours plus ampicillin 2gm intravenously every 6 hours. For all
patients, clindamycin will be given intravenously at the time of clamping of the umbilical
cord in the event of a cesarean delivery, and continued as part of the antibiotic regimen as
per standard of care for cesarean section in the setting of chorioamnionitis. With the
exception of the saline placebo doses, both the Unasyn regimen and the ampicillin/gentamicin
regimen are efficacious and widely utilized regimens for the treatment of intrapartum
chorioamnionitis, and do not represent a deviation from standard of care. After delivery, if
the patient experiences a treatment failure as defined below, her medical care will be
managed at the discretion of the attending physician as per standard of care, and her
antibiotic regimen will be unblinded. After delivery, prior to discharge from the hospital,
the patient will be asked to answer a short questionnaire enquiring about side effects
experienced during treatment for chorioamnionitis. The patient may receive a phone call
within 14 days of delivery to assess whether she has received treatment for postpartum
complications at an outside institution after discharge from the hospital.

Inclusion Criteria:

1. Pregnant women in labor or undergoing induction of labor

2. Greater than or equal to 18 years of age

3. Diagnosed with chorioamnionitis as defined by maternal temperature > or = 38.0 degrees
Centigrade plus at least one of the following: maternal tachycardia (heart rate >110),
fetal tachycardia (fetal heart rate baseline >160), purulent amniotic fluid, uterine
tenderness.

Exclusion Criteria:

1. Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam

2. Having received antibiotics for the treatment of preterm premature rupture of
membranes or other condition within the last 7 days

3. Acute or chronic renal disease or insufficiency (creatinine >1.0)

4. Hearing loss

5. Major fetal congenital anomalies or intrauterine fetal demise

6. Neutropenia

7. HIV

8. Myasthenia gravis or other neuromuscular disorder