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.: PACTR201601001428921 Date of Approval: 17/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized Trial Comparing Foley Catheter, Oxytocin and combination Foley catheter-Oxytocin for Induction of Labour with Unfavourable Cervix
Official scientific title A Randomized Trial Comparing Foley Catheter, Oxytocin and combination Foley catheter-Oxytocin for Induction of Labor with Unfavourable Cervix in Egyption Delta
Brief summary describing the background and objectives of the trial Compare efficacy of transcervical foley catheter and oxytocin for induction of labour with Unfavourable Cervix in Egyption Delta Region
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 17/01/2016
Actual trial start date 17/01/2016
Anticipated date of last follow up 17/02/2016
Actual Last follow-up date 17/02/2016
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer randomization tables sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group transcervical catheter with out oxytocin inflated with 30 ml saline 12 hours foley catheter is introduced in cervix and inflated with saline for 12 hours until cervix is ripe 3cm then augment labour with oxytocin 36 Uncontrolled
Experimental Group transcervical catheter with oxytocin 5 units oxytocin in 500 ml glucose 5% at rate 5 drops per min and increased gradually till adequate uterine contractions are obtained 12h transcervical foley catheter is introduced in the cervix with simultaneous oxytocin in the same time 36 Uncontrolled
Experimental Group oxytocin alone 5 units oxytocin in 500 ml glucose 5% at rate 5 drops per min and increased gradually till adequate uterine contractions are obtained 12 hours oxytocin is administered alone for induction of labour with same dose and rate as described 36 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton pregnancy 28 weeks or more with indication for induction of labor Unfavourable Cervix No contraindication for vaginally delivery Maternal or fetal contraindication for induction of labor 18 Year(s) 38 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 04/01/2015 menoufia university hospital local ethical committee
Ethics Committee Address
Street address City Postal code Country
yassin abd elghafar shibin elkom 32465 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome preinduction bishop score,cervical ripening interval, induction delivery interval,route of delivery Before, during and after delivery
Secondary Outcome adverse maternal and fetal effects During and afterdelivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
obstetrics and gynecology department.Faculty of medicine.menoufia university yassin abd elghafar street shibin elkom 32465 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufia university yassin abd elghafar street shibin elkom 32465 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia university yassin abd elghafar street shibin elkom 32465 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nabih elkhouly yassin abd elghafar street shibin elkom 32465 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology.faculty of medicine.menoufia university
Role Name Email Phone Street address
Public Enquiries nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology.faculty of medicine.menoufia university
Role Name Email Phone Street address
Scientific Enquiries nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology.faculty of medicine.menoufia 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