SU-03192009-2018

About this trial

Last updated 7 years ago

Study ID

SU-03192009-2018

Status

Completed

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

Accepting

18 to 55 Years

Female

Not accepting

Healthy Volunteers

Trial Timing

Ended 13 years ago

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.

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

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