Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

NCT ID: NCT04062175

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-07-18

Brief Summary

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efficacy of adding azithromycin to cephalosporin before cesarean delivery

Detailed Description

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efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Conditions

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Wound Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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cephalosporin arm

72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision

Group Type ACTIVE_COMPARATOR

cephalosporin

Intervention Type DRUG

72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision

cephalosporin +azithromycin arm

72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision

Group Type ACTIVE_COMPARATOR

cephalosporin

Intervention Type DRUG

72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision

Azithromycin Tablets

Intervention Type DRUG

72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision

Interventions

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cephalosporin

72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision

Intervention Type DRUG

Azithromycin Tablets

72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age between 17 and 39 years
* gestaional age between 37 to 42 weeks
* elective cesarean delivery
* obese women

Exclusion Criteria

* diabetic women on corticosteroids
* intraopertaive complication in previous section
* history of septic woun
* prelabour rupture of membrane \>12 hours
Minimum Eligible Age

17 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ghada fayed hashem el sharkawy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reda Mokhtar, MD

Role: PRINCIPAL_INVESTIGATOR

AinShams university ,egypt el abbasia

Locations

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Ain Shams maternity hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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55

Identifier Type: -

Identifier Source: org_study_id

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