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Clinical Trials/CTRI/2024/04/065067
CTRI/2024/04/065067CompletedPhase 2

Randomised controlled trial between single dose Azithromycin and ceftriaxone verses ceftriaxone alone in a case of prelabour cesarean birth to decrease surgical site infection

Dr. Yogesh baburao Munde1 site in 1 country1,980 target enrollmentStarted: April 10, 2024Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
1,980
Locations
1
Primary Endpoint
1. Reduce surgical site infection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomised controlled trial between single dose Azithromycin and ceftriaxone alone verses ceftriaxone alone in a case of prelabour cesarean birth ,

Purpose to decrease surgical site infection.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Pregnant after 37 weeks with indication breech, previous c-ection, placenta previa.

Exclusion Criteria

  • •Allergy to Azithromycin,contraindications,women in active labour, preterm labour,twins ,Maternal condition.

Outcomes

Primary Outcomes

1. Reduce surgical site infection

Time Frame: Once weekly

2.reduce endometritis

Time Frame: Once weekly

3.improve maternal and neonatal outcomes

Time Frame: Once weekly

4.safety profile

Time Frame: Once weekly

Secondary Outcomes

  • Evidence based practice(Advancement of knowledge)

Investigators

Sponsor
Dr. Yogesh baburao Munde
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Yogesh baburao Munde

Institute of postgraduate medical education and research Kolkata

Study Sites (1)

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