NCT04763486

Brief Summary

Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

July 29, 2019

Last Update Submit

February 20, 2021

Conditions

Puerperal Infection

Outcome Measures

Primary Outcomes (1)

  • Number of participants with a fever after delivery

    Maternal fever above 38 C (Celsius)

    6 weeks of delivery

Secondary Outcomes (1)

  • Way of delivery

    6 weeks of delivery

Study Arms (2)

Prophylactic antibiotic treatment

EXPERIMENTAL

Will be given Cefamezin antibiotic within 6 hours of delivery

Drug: Cefazolin (Cefamezin)

No intervention

NO INTERVENTION

Will not get antibiotic prophylactics

Interventions

Cefazolin (Cefamezin)DRUG

Cefamezin 2 gr within 6 hour of delivery

Prophylactic antibiotic treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDelivery
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45
  • perineal tear 2nd and 1st degree( episiotomy)

You may not qualify if:

  • rd and 4 th degree perineal tear
  • antibiotic indication during delivery
  • cesarian section delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 11125, Israel

Location

MeSH Terms

Conditions

Puerperal Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Pregnancy Complications, InfectiousInfectionsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal Disorders

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gil Shechter, Dr

    Meir Medical Center , Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Daykan, Dr

CONTACT

+972542198231yair.dykan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parturition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

February 21, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

IL(1)