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.: PACTR202209817035302 Date of Approval: 26/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hysteroscopic Resection Of Cesarean Uterine Scar Defect Versus Levonorgestrel-releasing Intrauterine Device In Management of Patients With Postmenstrual Spotting : A Comparative study
Official scientific title Hysteroscopic Resection Of Cesarean Uterine Scar Defect Versus Levonorgestrel-releasing Intrauterine Device In Management of Patients With Postmenstrual Spotting : A Comparative study
Brief summary describing the background and objectives of the trial Cesarean deliveries are one of the most common performed surgical intervention accounting worldwide for one-third of all deliveries and they have long-term morbidity related to a defect in the uterine cesarean section scar, also called a niche. Postmenstrual spotting is the most common symptom that reported in 29%-82% patients with a niche. In this study, the efficacy of hysteroscopic resection of niche will be compared with a Levonorgestrel-releasing intrauterine device (LNG-IUD, 52 mg) on postmenstrual spotting in patients with a symptomatic niche in the uterine cesarean scar. Through prospective cohort study that will be conducted at the department of Obstetrics and Gynecology ,Suez Canal University Hospitals on 48 Patients with postmenstrual spotting symptomatic niches and they will be allocated to hysteroscopy group or LNG-IUD group based on random allocation after fulfillment of inclusion criteria , and will be followed up for 6 months after treatment. Reducing postmenstrual spotting days at 6th month after treatment will be the primary outcome. By the end of this study, we can compare the effect of hysteroscopic niche resection and LNG-IUD on reducing niche related postmenstrual spotting.
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 postmenstrual bleeding
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Active, not 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group hysteroscopic resection hysteroscopic resection 6 month follow up hysteroscopic resection group 24 Active-Treatment of Control Group
Experimental Group LNG group LNG IUS will be inserted 6 months LNG-IUS group 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients aged between 20 and 45 years - Women with a previous caesarean section (at least one previous cesarean delivery) - postmenstrual spotting of at least two days and in whom ultrasound had shown a niche, they are considered to undergo a hysteroscopic niche resection or to receive LNG-IUD (52 mg) insertion. - Fertility wish within 1 year - Irregular menstrual cycle before the last cesarean delivery, - Presence of an intrauterine device - Coagulopathy - The length of the uterine cavity less than 6 cm or more than 10 cm - Current exogenous hormone treatment - Other gynecological conditions that could cause prolonged bleeding such as leiomyoma, endometrial hyperplasia, ovarian endometriosis and pregnancy - Patients had received hysteroscopic resection or LNG-IUD before intervention - In hysteroscopy group, additional exclusion criteria are contraindication for general anesthesia and with residual myometrium thickness (RMT) less than 2.2 mm to prevent bladder injury and uterine perforation. Adult: 19 Year-44 Year 18 Year(s) 45 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 29/11/2021 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reducing spotting days at the 6th month after treatment based on the intention-to-treat (ITT) analyses. We also will analyze the effectiveness rate (defined as proportion of patients with spotting days reduced by at least 50% from baseline), menstrual characteristics (e.g., duration of menstruation, total bleeding days per month, amenorrhea is defined as no menstruation/irregular bleeding or spotting for at least 3 months, patients’ satisfaction of menstruation (5-point Likert scale) and direct medical costs (including the costs of preoperative examination, medical consumption and the surgery) at each follow-up point based on both ITT and per protocol analyses. If additional LNG-IUD is applied in hysteroscopy group or if an IUD is removed in LNG-IUD group because of symptoms, it will be considered as a failure. Pregnant women will be deleted from the study starting with the cycle of conception. 6 months
Secondary Outcome Intraoperative complications will be recorded in the Electronic Medical Record. Postoperative complications and side effects will be evaluated using digital questionnaires, these included questions on urinary tract injury, fever, infection, breast pain, pelvic pain, emotional wings, depression, weight changes and acne. side effects of LNG-IUS 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
esraa Mohamed Abd Elfatah Mohamed ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university ring road ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
esraa Mohamed Abd Elfatah Mohamed ring road kilo 4.5 ismailia Egypt
Mohamed Amr Mohamed Samy khodair ring road kilo 4.5 ismailia Egypt
Hanan Mohamed Ghoneim ring road kilo 4.5 ismialia Egypt
Amira Mohamed Elbahy ring road kilo 4.5 ismialia Egypt
Mahmoud Ahmed Greash ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esraa Abd Elfatah dr.esraa111@yahoo.com 01000543612 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries hanan ghoneim hananghoneim@gmail.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries esraa Abd Elfatah dr.esraa111@yahoo.com 01000543612 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing is permited upon reasonable request and after approval of the research ethics committee Study Protocol after completion of the study after approval of the research 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