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.: PACTR201701001953325 Date of Approval: 02/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided IUD insertion in RVF
Official scientific title Ultrasound guided IUD insertion in RVF uterus :RCT
Brief summary describing the background and objectives of the trial we will use ultrasound to guide IUD insertion with full bladder ,by a way similar to embryo transfer
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 01/01/2018
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group US guided IUD insertion day 8 US guided IUD insertion 200
Control Group traditional insertion IUD insertion day 8 IUD insertion without US 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all female in reproductive age seeking contraception all contraindication to IUD : abnormal genital bleeding, pelvic infection,amenorrhea,uterine anomalies 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
No 02/03/2017 CUH
Ethics Committee Address
Street address City Postal code Country
Kasr alainy Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome easiness,pain during insertion
Secondary Outcome complications, time needed for insertion during or just after insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital(CUH) Kasralainy Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH Kasralainy Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH Kasralainy Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Nabil 160 King Faisal Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 00201111765934 24 abdelrahman albarkoky -almanyal
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Hala Nabil fawzy.jana@yahoo.com 00201002412549 160 King Faiasl
City Postal code Country Position/Affiliation
Giza 12613 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 Said zulfakar
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