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.: PACTR202108487478996 Date of Registration: 04/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hyaluronic Acid Gel, Intrauterine Device or Both for prevention of Intrauterine Adhesions after Hysteroscopic Myomectomy
Official scientific title Hyaluronic Acid Gel, Intrauterine Device or Both for prevention of Intrauterine Adhesions after Hysteroscopic Myomectomy
Brief summary describing the background and objectives of the trial Women diagnosed with vaginal ultrasound to have uterine fibroid FIGO type 0,1,2 less than 4cm will undergo hysteroscopic myomectomy at the end of the procedure group A will receive NCH gel to prevent adhesion , group B will insert IUD ang group c will receive both. The aim is to investigate the efficacy of hyaluronic acid gel, intrauterine device or both for preventing intrauterine adhesions after hysteroscopic myomectomy
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 intrauterine adhesions after hysteroscopic myomectomy
Purpose of the trial using NCH gel , IUD insertion or both to prevent intrauterine adhesions after hysteroscopic myomectomy
Anticipated trial start date 15/08/2021
Actual trial start date
Anticipated date of last follow up 15/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Group A 5 ml of the NCH gel injected intrauterine 3 months follow up and then second look hysteroscopy to assess presence of adhesions injection of NCH gel intrauterine after myomectomy 25 Active-Treatment of Control Group
Experimental Group Group B intrauterine device insertion after myomectomy 3 months follow up and then second look hysteroscopy to assess presence of adhesions IUD insertion after myomectomy 25
Experimental Group Group C insertion of both NCH gel and IUD inntrauterine after hysteroscopic myomectomy 3 months follow up and then second look hysteroscopy to assess presence of adhesions insertion of both NCH gel and IUD inntrauterine after hysteroscopic myomectomy 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- patients diagnosed by vaginal ultrasounography to have single or multiple submucous fibroid type 0,1and type 2 if less than 4cm according to FIGO classification. 2-women aged aged 25-60 3- patients with no history of previous adhesions 4- a signed written consent 5- consent to have a second look hysteroscopy 1-type 2 fibroid more than 4 cm 2-hypersensetivity to hyaluroinic acis gel or IUD 3-patients with fiboroid type 3 or more 4- genital tract malformation 5- genital infection Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 60 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 30/08/2020 research ethics committee faculty of medicine Suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road ismailia egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to assess the efficacy of 3 different techniques for prevention of intrauterine adhesions formation after hysteroscopic myomectomy 3 months after intervention by second look hysteroscopy
Secondary Outcome to assess endometrial thickness in all study groups after hysteroscopic myomectomy 3 months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital Ring road,4.5km,ismailia,egypt ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed salah 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 cana university ring road 4.5km ismailia egypt ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
suez canal university ring road 4.5km ismailia egypt ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zakia mahdy zakiamahdyaboelill@yahoo.com 01007537438 ring road kilo 4.5 salam district
City Postal code Country Position/Affiliation
ismailia 41522 Egypt university
Role Name Email Phone Street address
Public Enquiries ahmed salah Dr_ahmedsalah5@yahoo.com 01227944317 ringroad kilo 4.5 ismailia
City Postal code Country Position/Affiliation
ismailia 41522 Egypt university
Role Name Email Phone Street address
Scientific Enquiries ahmed salah Dr_ahmedsalah5@yahoo.com 01227944317 ring road 4.5 km ismailia
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