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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.
Register: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201610001806300
Date of registration: 04/10/2016
Prospective Registration: No
Primary sponsor: CUH
Public title: Effect of rectal enema during labor on bacterial colonization in neonate
Scientific title: Effect of rectal enema during labor on bacterial colonization in neonate
Date of first enrolment: 01/01/2016
Target sample size: 200
Recruitment status: Complete
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1806
Study type:  Interventional
Study design:  Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program  
Phase:  Not Applicable
Countries of recruitment
Egypt
Contacts
Name: Yosra     Hassan
Address:  24 albarkoky st almanyal 11555 Cairo Egypt
Telephone: 01111766018
Email: yosran3@gmail.com
Affiliation:  Cairo University
Name: Mohamed     Awad
Address:  zulfakar st 11555 Cairo Egypt
Telephone: 01005034393
Email: m_oj_h@yahoo.com
Affiliation:  Cairo University
Key inclusion & exclusion criteria
Inclusion criteria: 37-42weeks
20-40 years

Exclusion criteria: premature rupture of membrane
CS
neonatal sepsis


Age minimum: 20 Year(s)
Age maximum: 40 Year(s)
Gender: Female
Health Condition(s) or Problem(s) studied

Neonatal Diseases
Pregnancy and Childbirth
obtetrics, microbiology
Neonatal Diseases
obtetrics, microbiology
Pregnancy and Childbirth
Intervention(s)
no enema
saline enema
Primary Outcome(s)
detection of clstridium difficile in neonatal stool
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
CUH
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 01/01/2016
Contact:
CUH ethical committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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