Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
Status unconfirmed · Phase 2
Conditions studied: Endometritis, Cesarean Section; Infection, Wound Infection
In brief
Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.
Key facts
- Study ID
- NCT03960970
- Run by
- RWJ Barnabas Health at Jersey City Medical Center
- People needed
- 800
- Starts
- 2019-09-15
- Expected to finish
- 2020-11-30
- Last updated by the study team
- 2019-09-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women 18 years or older
- Women undergoing primary or repeat cesarean delivery
- Singleton gestation
- Gestational age greater than 34 weeks
- Pregnant patients undergoing scheduled cesarean delivery
- Intact membranes
- Non-laboring
- Signed informed consent
You may not qualify if…
- Maternal age < 18 years
- Multi-fetal gestation
- Known allergy to cephalosporin or azithromycin
- Patient unwilling or unable to provide consent
- Diagnosis of rupture of membranes
- Intraamniotic infection, or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
- Immunocompromising medical conditions: HIV positive with CD4 count below 200, chronic steroid use, current diagnosis of cancer and/or chemotherapy age use
- Emergent cesarean precluding consent or availability of study medication
- Need for hysterectomy at time of delivery
- Use of antibiotic in the 72 hours prior to admission, with exception to patient receiving antibiotics for GBS
- Inability to contact patient on postpartum period.
Where it is running
- Jersey City Medical Center — Jersey City, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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