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.: PACTR202009852042130 Date of Approval: 22/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Levonorgestrel Intrauterine System versus Copper intrauterine device on uterine artery Doppler indices
Official scientific title Effects of Levonorgestrel Intrauterine System versus Copper intrauterine device on uterine artery Doppler indices
Brief summary describing the background and objectives of the trial Intra uterine contraceptive devises (copper device or levonorgestrel releasing intrauterine system/ LNG- IUS) are considered long acting reversible contraceptives with long term efficacy that resembles sterilization (1). However, both were associated with bothering side effects as prolonged/irregular bleeding and heavy menstrual bleeding in LNG- IUS and copper IUD users, respectively (2, 3). However, the LNG- IUS was associated with atrophic changes in the endometrium and reduced menstrual blood loss (4). It also was associated with changes in the endometrial vasculature as demonstrated in endometrial biopsies in the form of decreased mean vascular density and increased mean vessel area (5). Recognizing the changes in the uterine vasculature rendered to IUD usage would be helpful during patient counseling when they request contraception (6) as up to 20% of the copper IUD users request removal because of the side effects (7). The available research documented conflicting results about the effect of the LNG- IUS on uterine artery Doppler indices (6, 8-13). Additionally, conflicting results exist regarding the relation between the copper IUD and increased menstrual blood loss (14- 16). The current study aimed at evaluating the effect of LNG- IUS and copper IUD on uterine vasculature after 3 months of use.
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 family planning
Purpose of the trial Supportive care
Anticipated trial start date 01/11/2019
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
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
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 copper iud iud was inserted and follow up was done at 3 and 6 months 6 months uterine artery doppler measurement 33 Active-Treatment of Control Group
Experimental Group LNG IUS group LNG- IUS was inserted and follow up was done at 3 and 6 months 6 months uterine artery doppler was measured at 3 and 6 months after insertion 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women with a normal menstrual cycle attending the family planning clinic requesting long-acting reversible contraception, and b) aging from 18-45 years. a) Nulliparity, b) pregnancy, c) undiagnosed uterine bleeding, d) genital infection in the preceding month, e) bleeding disorders contradicting copper IUD insertion, f) any contraindication to progestin administration or IUD insertion, g) patients on NSAIDs before IUD insertion, and h) Uterine anomalies, adenomyosis, or leiomyoma. Adult: 19 Year-44 Year 19 Year(s) 44 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 28/10/2019 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 a) changes in uterine artery Doppler indices 3 and 6 months after insertion b) menstrual changes. 6 months
Secondary Outcome The secondary outcome measures were the adverse effects of the contraceptive method and patient acceptability. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university round road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sally S. Mahmoud 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 kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rasha E. khamees ring road, kilo 4.5 ismailia Egypt
Eman A. Kishk ring road, kilo 4.5 ismailia Egypt
Sally S. Mahmoud ring road, kilo 4.5 ismailia Egypt
Mamdouh E. Said ring road, kilo 4.5 ismailia Egypt
Omima Tharwat Taha ring road, kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sally mahmoud sallymahmoud@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.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 omima taha omimatharwat@yahoo.com 01223423685 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 will be through the results available in the manuscript Study Protocol after publishing the paper after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/09/2020 19/09/2020
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