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Prophylactic Antibiotics After Cesarean

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Statusİşə qəbul
Sponsorlar
The University of Texas Medical Branch, Galveston

Açar sözlər

Mücərrəd

The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.

Təsvir

The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics & Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.

In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.

All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.

Tarixlər

Son Doğrulandı: 04/30/2020
İlk təqdim: 06/11/2017
Təxmini qeydiyyat təqdim edildi: 06/11/2017
İlk Göndərmə: 06/13/2017
Son Yeniləmə Göndərildi: 05/04/2020
Son Yeniləmə Göndərildi: 05/06/2020
Həqiqi Təhsilin Başlama Tarixi: 07/31/2017
Təxmini İlkin Tamamlanma Tarixi: 07/30/2021
Təxmini İşin Tamamlanma Tarixi: 12/30/2021

Vəziyyət və ya xəstəlik

Surgical Site Infection

Müdaxilə / müalicə

Drug: Cephalexin and metronidazole

Drug: Placebo / standard of care

Drug: Cephalexin and metronidazole

Faza

Faza 1

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: Cephalexin and metronidazole
500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses
Drug: Cephalexin and metronidazole
Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
Placebo Comparator: Placebo / standard of care
Placebo pills per oral every 8 hours for a total of 6 doses
Drug: Placebo / standard of care
Placebo representing standard of care

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərFemale
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- Women >18 and <50 years

- BMI >30kg/m2

- Decision by clinical team to perform Cesarean section

- Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)

Exclusion Criteria:

- Subject unwilling or unable to provide consent

- No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery

- Fetal demise or major congenital anomaly

- Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other

- Diagnosis or suspicion of chorioamnionitis prior to randomization

- Other planned post-operative antibiotic administration

- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)

- Known allergy or contraindication to cephalosporins or metronidazole

- Incarcerated individuals

Nəticə

İlkin nəticə tədbirləri

1. Surgical site infection [6 weeks postpartum]

Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess

İkincili Nəticə Tədbirləri

1. Maternal mortality [6 weeks (42 days) postpartum]

Maternal death

2. Febrile morbidity [6 weeks (42 days) postpartum]

If the patient develops a measured temperate greater than or equal to 100.4 degrees Fahrenheit (or 38.0 degrees Celsius), she will have a postpartum fever.

3. Postpartum antibiotic use [6 weeks (42 days) postpartum]

We will assess via chart review and direct patient inquiry whether or not antibiotics were taken by the patient for any purpose during the six weeks (42 days) immediately following delivery.

4. Wound hematoma or seroma [6 weeks (42 days) postpartum]

Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma

5. Use of resources [6 weeks (42 days) postpartum]

We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures

6. Other adverse events [6 weeks postpartum]

Such as allergic reaction to study medications

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