Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Condition: Chorioamnionitis
MeSH terms: Chorioamnionitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters)
      surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat
      common and is routinely treated with antibiotics given to the mother both before and after
      the baby is born. Currently it is not known what is the best choice of antibiotics to treat
      this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or
      ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if
      one is better than the other at treating and preventing bad outcomes from chorioamnionitis in
      women and babies.
    

Detailed description: 
      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.
    

Intervention name(s): Unasyn; Ampicillin/gentamicin
Intervention type(s): Drug; Drug
Intervention description(s): Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.; Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Intervention MeSH terms: Gentamicins; Ampicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment