Trial · NCT01235546
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
NCT01235546, Not applicable, Completed, Alan Tita; results first posted 2017-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection. Trials, record NCT01235546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01235546
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
- NCT number
- NCT01235546
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,013 participants, actual
- Lead sponsor
- Alan Tita
- Conditions
- Endometritis, Wound Infection, Abscess, Surgical Site Infection
- Interventions
- Azithromycin and standard of care, Placebo and standard of care
- First posted
- 2010-11-05
- Last updated
- 2017-07-28
- Results first posted
- 2017-07-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) | Up to 6 weeks after delivery | Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \[100.4°F\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection. |
| Other | Neonatal Morbidities (Listed Below) | Up to 3 months after birth | morbidities include: death, Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Periventricular Leukomalacia (PVL) suspected or proven sepsis, Necrotizing Enterocolitis (NEC) Intraventricular Hemorrhage (IVH) and systemic inflammatory response syndrome |
| Other | Neonatal Intensive Care Unit (NICU) Admission | Up to 3 months after birth | Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure. |
| Other | Neonatal Readmission | Up to 3 months after birth | |
| Other | Maternal Fever | Up to 6 weeks after delivery | |
| Other | Maternal Postpartum Readmission or Unscheduled Visit | Up to 6 weeks after delivery | Maternal postpartum unscheduled visit or readmission to the hospital |
| Other | Maternal Postpartum Antibiotic Use | Up to 6 weeks after delivery | Maternal postpartum use of antibiotics |
| Other | Maternal Serious Adverse Events | Up to 6 weeks after delivery | All maternal serious adverse events |
| Other | Neonatal Serious Adverse Events | Up to 3 months after birth | Composite for all neonatal serious adverse events |
| Other | Infant Pyloric Stenosis | up to 3 months after birth | Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) | Up to 6 weeks after delivery | The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Neonatal Morbidities (Listed Below) | Up to 3 months after birth | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Neonatal Intensive Care Unit (NICU) Admission | Up to 3 months after birth | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Neonatal Readmission | Up to 3 months after birth | Hospitalization after discharge | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Maternal Fever | Up to 6 weeks after delivery | Postpartum Fever | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Maternal Postpartum Readmission or Unscheduled Visit | Up to 6 weeks after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Maternal Postpartum Antibiotic Use | Up to 6 weeks after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Maternal Serious Adverse Events | Up to 6 weeks after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Neonatal Serious Adverse Events | Up to 3 months after birth | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Infant Pyloric Stenosis | up to 3 months after birth | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) | Placebo | 119 | Participants | ||
| Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) | Azithromycin | 62 | Participants | ||
| Neonatal Morbidities (Listed Below) | Placebo and Standard of Care | 135 | Participants | ||
| Neonatal Morbidities (Listed Below) | Azithromycin and Standard of Care | 146 | Participants | ||
| Neonatal Intensive Care Unit (NICU) Admission | Placebo and Standard of Care | 169 | Participants | ||
| Neonatal Intensive Care Unit (NICU) Admission | Azithromycin and Standard of Care | 171 | Participants | ||
| Neonatal Readmission | Placebo With Standard Prophylaxis | 43 | Participants | ||
| Neonatal Readmission | Azithromycin (Zithromax) With Standard Prophylaxis | 39 | Participants | ||
| Maternal Fever | Placebo With Standard Prophylaxis | 81 | Participants | ||
| Maternal Fever | Azithromycin (Zithromax) With Standard Prophylaxis | 51 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo and Standard of Care | 994 | |
| Overall Study | STARTED | Azithromycin and Standard of Care | 1,019 | |
| Overall Study | COMPLETED | Placebo and Standard of Care | 992 | |
| Overall Study | COMPLETED | Azithromycin and Standard of Care | 1,018 | |
| Overall Study | NOT COMPLETED | Placebo and Standard of Care | 2 | |
| Overall Study | NOT COMPLETED | Azithromycin and Standard of Care | 1 |
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 | ICU admission | General disorders | Placebo and Standard of Care | 14 | 992 | 14 |
| other | ICU admission | General disorders | Azithromycin and Standard of Care | 9 | 1,018 | 9 |
| serious | Severe allergic reaction | Immune system disorders | Placebo and Standard of Care | 29 | 992 | 29 |
| serious | Severe allergic reaction | Immune system disorders | Azithromycin and Standard of Care | 15 | 1,018 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo and Standard of Care | 0 | 992 |
| Total, all-cause mortality | Azithromycin and Standard of Care | 0 | 1,018 |
| Total, other adverse events | Placebo and Standard of Care | 14 | 992 |
| Total, other adverse events | Azithromycin and Standard of Care | 9 | 1,018 |
| Total, serious adverse events | Placebo and Standard of Care | 29 | 992 |
| Total, serious adverse events | Azithromycin and Standard of Care | 15 | 1,018 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Maternal Postpartum Antibiotic Use | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Neonatal Serious Adverse Events | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Maternal Serious Adverse Events | Trial comparisons |
| Placebo With Standard Prophylaxis vs Azithromycin (Zithromax) With Standard Prophylaxis: Neonatal Readmission | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Neonatal Morbidities (Listed Below) | Trial comparisons |
| Azithromycin vs Placebo: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Infant Pyloric Stenosis | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Maternal Postpartum Readmission or Unscheduled Visit | Trial comparisons |
| Placebo With Standard Prophylaxis vs Azithromycin (Zithromax) With Standard Prophylaxis: Maternal Fever | Trial comparisons |
| Placebo and Standard of Care vs Azithromycin and Standard of Care: Neonatal Intensive Care Unit (NICU) Admission | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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/NCT01235546
GET https://conductscience.org/api/trials/v1/NCT01235546/registered