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.: PACTR202005716478451 Date of Approval: 19/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title hysteroscopic resection of uterine caesarean scar defect in patients with postmenstrual spotting
Official scientific title hysteroscopic resection of uterine caesarean scar defect in patients with postmenstrual spotting
Brief summary describing the background and objectives of the trial prospective controlled clinical trial for women with postmenstrual spotting due to CS scar defect that will be managed by hysteroscopic resection and followed up after 3 months and reassessed for spotting, sexual life, urological symptoms, and quality of life and compared to whom with CS scar defect with expectant management.
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 post menstrual spotting and CS scar defect
Purpose of the trial Hysteroscopic resection of CS scar defect
Anticipated trial start date 23/05/2020
Actual trial start date
Anticipated date of last follow up 01/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization 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
Control Group control group patients will be assessed by questionnaire about their menstrual pattern and uterine bleeding , quality of life and sexual function 3 months no intervention 35 Placebo
Experimental Group study group patients will be assessed by history and examination and ultrasound then questionnaire about their menstrual pattern and uterine bleeding and quality of life and sexual pattern. then hysteroscopic resection of CS scar defect and reassessed by the same questionnaire after 3months 3 months hysteroscopic resection of uterine CS scar defect 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-women with a previous caesarean section at least one previous caesarean delivery who presented with postmenstrual spotting and in whom sonohysterography had shown a niche with residual myometrium of at least 3 mm within one year of the last caesarean delivery. 2-women at reproductive age 18-40 years 1- women under the age of 18 2- pregnancy 3- suspected malignancy 4- patients using IUD, OCP, GnRH agonists 5- patients with uterine or cervical polyp 6-patients with endocrinological disorders Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 19/09/2018 research ethics committee faculty of medicine Suez canal university
Ethics Committee Address
Street address City Postal code Country
Ring Road 4.5 Km Ismailia Egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to measure the prevalence of prolonged postmenstrual bleeding after hysteroscopic resection of the niche versus expectant management 3 months after intervention
Secondary Outcome to assess the effect of hysteroscopic niche resection on quality of life, sexual function and urological symptoms 3 months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez canal university Ring Road 4.5 Km , ismailia Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
omnia orabi mohammed Ring road 4.5 Km Ismailia Egypt Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university ring road 4.5 km ismailia Egypt Ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
suez canal university Ring Road 4.5km Ismalilia Egypt ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zakia mahdy zakiamahdyabolill@yahoo.com 01007537438 Ring Road kilo 4.5 el salam district
City Postal code Country Position/Affiliation
ismailia 41522 Egypt university
Role Name Email Phone Street address
Public Enquiries omnia orabi dr_monmon_88@yahoo.com 00201001884717 Ring Road Kilo 4.5 el salam district
City Postal code Country Position/Affiliation
ismailia 41522 Egypt university
Role Name Email Phone Street address
Scientific Enquiries omnia orabi dr_monmon_88@yahoo.com 00201001884717 ring road kilo4.5
City Postal code Country Position/Affiliation
ismailia 41522 Egypt university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing data will be through the recommendations of our ethics committee Study Protocol at the end of the trial through the ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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