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.: PACTR201409000878356 Date of Approval: 29/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Repeated pregnancy loss
Official scientific title Endometrial scratching in women with repeated first trimester pregnancy loss: A randomized controlled trial.
Brief summary describing the background and objectives of the trial To assess the value of endometrial scratching to improve live birth rate in repeated first trimester pregnancy loss.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Repeated pregnancy loss
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2014
Actual trial start date 01/09/2014
Anticipated date of last follow up 31/08/2015
Actual Last follow-up date 22/08/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endometrial scratching by Pipelle 1 minute Endometrial scratching by Pipelle for 1 minute 60
Control Group Sham technique 1 minute Pressure on the cervix by piece of gauze 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Repeated first trimester pregnancy loss. Known causes of habitual abortions: -Chromosomal abnormalities. -Uterine malformations. -Antiphospholipid syndrome. -Endocrine abnormalities as thyroid disorders and diabetes mellitus. 20 Year(s) 36 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 15/08/2014 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Live birth rate completion of pregnancy till delivery
Secondary Outcome clinical pregnancy rate visualization of gestational sac inside the uterus
Secondary Outcome miscarriage rate number of abortions
Secondary Outcome multiple pregnancy rate number of cases with multiple pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com +201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Abd-Elhamid Shaheen abdelhamidshaheen@yahoo.com +201221816916 10 Quesna
City Postal code Country Position/Affiliation
Shibin Elkom +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Tarek Sayyed tareksayed70@yahoo.com +201222739097 Nasr city
City Postal code Country Position/Affiliation
Cairo +202 Egypt
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information