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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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30 August 2021 |
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Main ID: |
PACTR202105874744483 |
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Date of registration:
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23/05/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Eight-hour versus 24-hour Urethral Catheter Removal Following Elective Caesarean Section for Reducing Bacteriuria: A Randomized Controlled Clinical Trial
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Scientific title:
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Eight-hour versus 24-hour Urethral Catheter Removal Following Elective Caesarean Section for Reducing Bacteriuria: A Randomized Controlled Clinical Trial |
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Date of first enrolment:
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20/03/2019 |
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Target sample size:
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300 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15892 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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George
Eleje |
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Address:
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Nnamdi Azikiwe University Teaching Hospital Nnewi campus
5025
nnewi
Nigeria |
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Telephone:
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+2348068117444 |
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Email:
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gu.eleje@unizik.edu.ng |
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Affiliation:
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Associate Professor Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi campus |
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Name:
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Ibraheem
Awowole |
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Address:
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Obafemi Awolowo University Teaching Hospital Complex Ife Central
220001
ile ife
Nigeria |
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Telephone:
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+2348033767719 |
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Email:
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drawo2001@yahoo.com |
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Affiliation:
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Consultant Obstetrician and Gynaecologist Obafemi Awolowo University Teaching Hospital Complex Ife Central |
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Key inclusion & exclusion criteria
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Inclusion criteria: a. Emergency Caesarean deliveries.
b. Elective Caesarean delivery with intra operative urinary bladder injury.
c. Failed spinal anaesthesia that may warrant conversion to general anaesthesia.
d. Pregnant women whose pre-operative mid-stream clean catch urine microscopy and culture
yielded significant bacteria growth.
Exclusion criteria: a. Emergency Caesarean deliveries.
b. Elective Caesarean delivery with intra operative urinary bladder injury.
c. Failed spinal anaesthesia that may warrant conversion to general anaesthesia.
d. Pregnant women whose pre-operative mid-stream clean catch urine microscopy and culture
yielded significant bacteria growth.
Age minimum:
19 Year(s)
Age maximum:
44 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy and Childbirth
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Pregnancy and Childbirth
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Primary Outcome(s)
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rate of bacteriuria and rate of urine retention ie need for recatheterization
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Secondary Outcome(s)
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time at first voiding , time until ambulation, duration of hospital stay , satisfaction rate
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Source(s) of Monetary Support
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igbodike emeka phlip
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Ethics review
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Status: Not approved
Approval date:
Contact:
oauthcethicscommittee@yahoo.com
Ethics Research committee Obafemi awolowo university teaching hospital complex ile ife
+2348152092753
oauthcethicscommittee@yahoo.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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