Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIH 1R01HD064729-01A1 | Other Grant/Funding Number | NICHD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Texas | OTHER |
| University of North Carolina | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.
Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and standard of care | Placebo Comparator | 250 cc normal saline |
|
| Azithromycin and Standard of care | Experimental | 500 mg Azithromycin in 250 cc normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin and standard of care | Drug | 500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of 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. | Up to 6 weeks after delivery |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Morbidities (Listed Below) | 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 | Up to 3 months after birth |
Inclusion Criteria:
-
Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan TN Tita, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Ochsner Clinic Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300334 | Background | Tita ATN, Rouse DJ, Blackwell S, Saade GR, Spong CY, Andrews WW. Emerging concepts in antibiotic prophylaxis for cesarean delivery: a systematic review. Obstet Gynecol. 2009 Mar;113(3):675-682. doi: 10.1097/AOG.0b013e318197c3b6. | |
| 12798523 | Background | Andrews WW, Hauth JC, Cliver SP, Savage K, Goldenberg RL. Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis. Obstet Gynecol. 2003 Jun;101(6):1183-9. doi: 10.1016/s0029-7844(03)00016-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The addition of azithromycin and the standard of care (cephazolin or clindamycin) for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin prophylaxis and the standard of care in women undergoing nonelective cesarean section.
Patients were randomly assigned to receive either azithromycin (at a dose of 500mg in 250 ml of saline, one time dose) or an identical-appearing saline placebo and the standard of care (cephazolin or clindamycin)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo and Standard of Care | Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin) |
| FG001 | Azithromycin and Standard of Care | Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Mission Hospital |
| UNKNOWN |
| Ochsner Health System | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Columbia University | OTHER |
| University of Utah | OTHER |
| University of Mississippi Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Placebo and standard of care | Drug | 250 cc normal saline, plus standard of care (cephazolin or clindamycin) |
|
|
| Neonatal Intensive Care Unit (NICU) Admission |
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. |
| Up to 3 months after birth |
| Neonatal Readmission | Up to 3 months after birth |
| Maternal Fever | Up to 6 weeks after delivery |
| Maternal Postpartum Readmission or Unscheduled Visit | Maternal postpartum unscheduled visit or readmission to the hospital | Up to 6 weeks after delivery |
| Maternal Postpartum Antibiotic Use | Maternal postpartum use of antibiotics | Up to 6 weeks after delivery |
| Maternal Serious Adverse Events | All maternal serious adverse events | Up to 6 weeks after delivery |
| Neonatal Serious Adverse Events | Composite for all neonatal serious adverse events | Up to 3 months after birth |
| Infant Pyloric Stenosis | Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation | up to 3 months after birth |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7516 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0587 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77225 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 18165392 | Background | Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39. |
| 38873885 | Derived | Martin JK, Longo SA, Jauk VR, Clark EAS, Saade GR, Boggess KA, Esplin S, Wapner RJ, Owens MY, Blackwell SC, Andrews WW, Szychowski JM, Tita AT. Neonatal outcomes in term and preterm infants following adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery. J Matern Fetal Neonatal Med. 2024 Dec;37(1):2367082. doi: 10.1080/14767058.2024.2367082. Epub 2024 Jun 14. |
| 35675601 | Derived | Sanusi A, Ye Y, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Owens M, Blackwell S, Szychowski JM, Tita ATN, Subramaniam A. Timing of Adjunctive Azithromycin for Unscheduled Cesarean Delivery and Postdelivery Infection. Obstet Gynecol. 2022 Jun 1;139(6):1043-1049. doi: 10.1097/AOG.0000000000004788. Epub 2022 May 2. |
| 28178058 | Derived | Boggess KA, Tita A, Jauk V, Saade G, Longo S, Clark EAS, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Blackwell S, Beamon C, Szychowski JM, Andrews W; Cesarean Section Optimal Antibiotic Prophylaxis Trial Consortium. Risk Factors for Postcesarean Maternal Infection in a Trial of Extended-Spectrum Antibiotic Prophylaxis. Obstet Gynecol. 2017 Mar;129(3):481-485. doi: 10.1097/AOG.0000000000001899. |
| 27682034 | Derived | Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo With Standard Prophylaxis | Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis |
| BG001 | Azithromycin (Zithromax) With Standard Prophylaxis | Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Smoking Prevalence | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of 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. | 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. | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Neonatal Morbidities (Listed Below) | 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 | Posted | Count of Participants | Participants | Up to 3 months after birth |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Neonatal Intensive Care Unit (NICU) Admission | 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. | Posted | Count of Participants | Participants | Up to 3 months after birth |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Neonatal Readmission | Hospitalization after discharge | Posted | Count of Participants | Participants | Up to 3 months after birth |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Maternal Fever | Postpartum Fever | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Maternal Postpartum Readmission or Unscheduled Visit | Maternal postpartum unscheduled visit or readmission to the hospital | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Maternal Postpartum Antibiotic Use | Maternal postpartum use of antibiotics | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Maternal Serious Adverse Events | All maternal serious adverse events | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Neonatal Serious Adverse Events | Composite for all neonatal serious adverse events | Posted | Count of Participants | Participants | Up to 3 months after birth |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Infant Pyloric Stenosis | Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation | Posted | Count of Participants | Participants | up to 3 months after birth |
|
|
Up to 6 weeks after delivery
Maternal serious adverse events (maternal safety composite outcome) included death, suspected allergic reactions (including anaphylaxis or generalized skin rash), any serious adverse event leading to the discontinuation of a study medication or suspected to be due to the medication, and any other reported serious adverse complication, including pulmonary embolism, admission to an intensive care unit (ICU), and cardiac events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo and Standard of Care | Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin) | 0 | 992 | 29 | 992 | 14 | 992 |
| EG001 | Azithromycin and Standard of Care | Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin) | 0 | 1,018 | 15 | 1,018 | 9 | 1,018 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe allergic reaction | Immune system disorders | Systematic Assessment | Allergy |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICU admission | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Tita, MD | University of Alabama at Birmingham, Maternal & Fetal Medicine | 205-934-9616 | atita@uab.edu |
| ID | Term |
|---|---|
| D004716 | Endometritis |
| D014946 | Wound Infection |
| D000038 | Abscess |
| D013530 | Surgical Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D059039 | Standard of Care |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|