Trial Outcomes & Findings for Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis (NCT NCT00879190)
NCT ID: NCT00879190
Last Updated: 2018-05-18
Results Overview
Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
92 participants
Primary outcome timeframe
Up to 24 hours after delivery
Results posted on
2018-05-18
Participant Flow
Participant milestones
| Measure |
Unasyn (Ampicillin/Sulbactam)
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
49
|
|
Overall Study
COMPLETED
|
43
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Baseline characteristics by cohort
| Measure |
Unasyn (Ampicillin/Sulbactam)
n=43 Participants
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
n=49 Participants
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
28.3 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
28.0 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nulliparous
|
30 participants
n=99 Participants
|
39 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Maternal pre-existing comorbidity
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours after deliveryProportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum
Outcome measures
| Measure |
Unasyn (Ampicillin/Sulbactam)
n=43 Participants
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
n=49 Participants
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
|---|---|---|
|
Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum
|
43 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks after deliveryComposite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.
Outcome measures
| Measure |
Unasyn (Ampicillin/Sulbactam)
n=43 Participants
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
n=49 Participants
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
|---|---|---|
|
Composite Maternal Morbidity
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks after deliveryOutcome measures
| Measure |
Unasyn (Ampicillin/Sulbactam)
n=43 Participants
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
n=49 Participants
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
|---|---|---|
|
Neonatal Clinical Sepsis (Early Onset)
|
1 affected neonates
|
2 affected neonates
|
Adverse Events
Unasyn (Ampicillin/Sulbactam)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ampicillin/Gentamicin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Unasyn (Ampicillin/Sulbactam)
n=43 participants at risk
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
|
Ampicillin/Gentamicin
n=49 participants at risk
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
2/43 • Number of events 2 • Adverse events were collected up to 6 weeks after delivery.
|
0.00%
0/49 • Adverse events were collected up to 6 weeks after delivery.
|
|
Infections and infestations
Postpartum endometritis
|
0.00%
0/43 • Adverse events were collected up to 6 weeks after delivery.
|
2.0%
1/49 • Number of events 1 • Adverse events were collected up to 6 weeks after delivery.
|
Additional Information
Anna Girsen, Manager of Maternal-Fetal Medicine Research Operations
Stanford University, Department of Obstetrics & Gynecology
Phone: (650) 725-0499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place