Phase 3
Completed N=92
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Source: ClinicalTrials.gov NCT00879190 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum — 43; 49 Participants — p=1.0
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum |
43; 49 | 1.0 |
| SECONDARY Composite Maternal Morbidity |
0; 6 | 0.03 sig |
| SECONDARY Neonatal Clinical Sepsis (Early Onset) |
1; 2 | 0.6 |
Eligibility Criteria
Inclusion Criteria
- Pregnant women in labor or undergoing induction of labor
- Greater than or equal to 18 years of age
- 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
- Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
- Having received antibiotics for the treatment of preterm premature rupture of membranes or other condition within the last 7 days
- Acute or chronic renal disease or insufficiency (creatinine >1.0)
- Hearing loss
- Major fetal congenital anomalies or intrauterine fetal demise
- Neutropenia
- HIV
- Myasthenia gravis or other neuromuscular disorder
Data sourced from ClinicalTrials.gov (NCT00879190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.