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Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.

Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014041017211N1
Enrollment
424
Registered
2014-05-05
Start date
2011-07-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To prevent post C/S infection. Delivery by emergency caesarean section

Interventions

Intervention 1: Control Group received Cephalotin 2gr IV and placebo 1gr oral. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48
Prevention
Control Group received Cephalotin 2gr IV and placebo 1gr oral. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surg
Case group received Azithromycin and Cephalotin as a preoperative antibiotic prophylaxis. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervi

Sponsors

Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to 44 Years

Inclusion criteria

Inclusion criteria: The single most important risk factor for postpartum maternal infection is cesarean section. Women undergoing cesarean section have greater risk for infection and infectious morbidity compared with a vaginal birth. The objective of this study is to determine if extended spectrum prophylactic antibiotic treatment (cefazolin and azithromycin) reduces post-cesarean delivery infections. Inclusion: spontaneously labor or induced labor; rupture of membranes within 4 hour prior the termination; meconium passage before section and non-cephalic presentation. Exclusion: diabetes; multiple Pregnancy; patients who have contraindication to receive antibiotics; history of Azitromycine or Erythromicine used in one last week; clinical finding about corioamniotitis; pulmonary edema; immunosupretion; Aids; patients who could not follow up after Cesarean section; significant renal disease; preeclampsia; rapture of membrane more than 18 hour. This randomized controlled double blind clinical trial was done on 424 women over 14 year with gestational age more than 24 week who underwent non- elective cesarean in Shariati Hospital in Bandar Abbas during 2011 July until 2012 August. Patients randomly divided to case and control group. Keflin 2 gram Intera Venus was prescribed 0.5 hour before surgery for both case and control groups. Cases also received azithromycin 1 gram oral 0.5 hour before surgery. Patients were under observed till 1 month after surgery. Fever; open wound; endometritis and hospitalization were compared between two groups.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Length of stay. Timepoint: After intervention. Method of measurement: Days of hospitalization after surgery.

Primary

MeasureTime frame
Fever. Timepoint: After intervention. Method of measurement: Thermometer in degrees Celsius.;Endometritis. Timepoint: After intervention. Method of measurement: Based on clinical symptoms such as fever, malodorous discharge and uterine tenderness.;Wound infection. Timepoint: After intervention. Method of measurement: Number of open stitches.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Abassian

Dr. Shariati Hospital, Hormozgan University of Medical Sciences

maryam.abbasian@hums.ac.ir+98 76 1333 2155

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026