Trial · NCT00879190
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
NCT00879190, Phase 2, Phase 3, Completed, Stanford University; results first posted 2017-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis. Trials, record NCT00879190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00879190
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
- NCT number
- NCT00879190
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Chorioamnionitis
- Interventions
- Unasyn, Ampicillin/gentamicin
- First posted
- 2009-04-09
- Last updated
- 2018-05-18
- Results first posted
- 2017-03-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum | Up to 24 hours after delivery | Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum |
| Secondary | Composite Maternal Morbidity | Up to 6 weeks after delivery | Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus. |
| Secondary | Neonatal Clinical Sepsis (Early Onset) | Up to 6 weeks after delivery |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum | Up to 24 hours after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Maternal Morbidity | Up to 6 weeks after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neonatal Clinical Sepsis (Early Onset) | Up to 6 weeks after delivery | affected neonates | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum | Unasyn (Ampicillin/Sulbactam) | 43 | Participants | ||
| Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum | Ampicillin/Gentamicin | 49 | Participants | ||
| Composite Maternal Morbidity | Unasyn (Ampicillin/Sulbactam) | 0 | Participants | ||
| Composite Maternal Morbidity | Ampicillin/Gentamicin | 6 | Participants | ||
| Neonatal Clinical Sepsis (Early Onset) | Unasyn (Ampicillin/Sulbactam) | 1 | affected neonates | ||
| Neonatal Clinical Sepsis (Early Onset) | Ampicillin/Gentamicin | 2 | affected neonates |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Unasyn (Ampicillin/Sulbactam) | 43 | |
| Overall Study | STARTED | Ampicillin/Gentamicin | 49 | |
| Overall Study | COMPLETED | Unasyn (Ampicillin/Sulbactam) | 43 | |
| Overall Study | COMPLETED | Ampicillin/Gentamicin | 49 | |
| Overall Study | NOT COMPLETED | Unasyn (Ampicillin/Sulbactam) | 0 | |
| Overall Study | NOT COMPLETED | Ampicillin/Gentamicin | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Unasyn (Ampicillin/Sulbactam) | 2 | 43 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Ampicillin/Gentamicin | 0 | 49 | 0 |
| other | Postpartum endometritis | Infections and infestations | Unasyn (Ampicillin/Sulbactam) | 0 | 43 | 0 |
| other | Postpartum endometritis | Infections and infestations | Ampicillin/Gentamicin | 1 | 49 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unasyn (Ampicillin/Sulbactam) | ||
| Total, all-cause mortality | Ampicillin/Gentamicin | ||
| Total, other adverse events | Unasyn (Ampicillin/Sulbactam) | 2 | 43 |
| Total, other adverse events | Ampicillin/Gentamicin | 1 | 49 |
| Total, serious adverse events | Unasyn (Ampicillin/Sulbactam) | 0 | 43 |
| Total, serious adverse events | Ampicillin/Gentamicin | 0 | 49 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Unasyn (Ampicillin/Sulbactam) vs Ampicillin/Gentamicin: Composite Maternal Morbidity | Trial comparisons |
| Unasyn (Ampicillin/Sulbactam) vs Ampicillin/Gentamicin: Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum | Trial comparisons |
| Unasyn (Ampicillin/Sulbactam) vs Ampicillin/Gentamicin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00879190
GET https://conductscience.org/api/trials/v1/NCT00879190/registered