Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001806300 Date of Approval: 04/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of rectal enema during labor on bacterial colonization in neonate
Official scientific title Effect of rectal enema during labor on bacterial colonization in neonate
Brief summary describing the background and objectives of the trial randomized trial to detect the effect of rectal enema on bacterial transmission from mother to neonate
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,obtetrics, microbiology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2016
Actual trial start date 03/05/2016
Anticipated date of last follow up 01/07/2016
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group saline enema 500 cc saline once during active phase 500 cc saline enema 100
Control Group no enema none none no enema 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
37-42weeks 20-40 years premature rupture of membrane CS neonatal sepsis 20 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/01/2016 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
kasralainy st Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome detection of clstridium difficile in neonatal stool first week of neonatal life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospital kasralainy st Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasralainy st Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasralainy st Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CU kasralainy st Cairo 11555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 01111765934 24 albarkoky almanyal
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awad m_oj_h@yahoo.com 01005034393 zulfakar st
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yosra Hassan yosran3@gmail.com 01111766018 24 albarkoky st almanyal
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information