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.: PACTR202307527164991 Date of Registration: 24/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of 30-minutes versus 60-minutes uterine artery occlusion tourniquet time during open myomectomy on levels of anti-mullerian hormone: a randomized clinical study in NAUTH, Nnewi, Nigeria.
Official scientific title Effect of 30-minute versus 60-minute uterine artery occlusion tourniquet time during open myomectomy on levels of ant-mullerian hormone: A randomized clinical study
Brief summary describing the background and objectives of the trial Background: Uterine fibroid is the most common of benign gynaecological tumours. One of the traditional methods of reduction of blood loss during open myomectomy is with application of uterine tourniquet. There remains concern to the effect of use of uterine tourniquet on ovarian reserve in women desirous of preserving their ovarian function. Ovarian reserve is the qualitative and quantitative availability of primordial follicles in the ovaries of a reproductive aged woman that can turn into mature follicles with reproductive potentials. Various forms of markers can be used to assess this including the static markers (oestradiol, follicle stimulating hormones, inhibin-B and anti-Mullerian hormone, AMH). Aim and Objectives: To evaluate the effect of uterine artery occlusion and duration of tourniquet time on ovarian reserve during open 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 Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/07/2023
Actual trial start date 10/07/2023
Anticipated date of last follow up 10/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 30 minute tourniquet time occlusion group Tourniquet is applied and left for 30minutes, after which it is removed and reapplied after 60seconds 30 minutes For participants in the first arm (30-minute tourniquet occlusion time) the tourniquet will be applied for a period of 30 minutes and removed thereafter. This will be reapplied for another 30 minutes if deemed necessary by the surgeon after 60 seconds of release 48
Control Group 60 minute tourniquet group Tourniquet is applied and left for 60minutes, after which it’s removed and left for 60 secs before reapplying 60 minutes For participants in the second arm (60-minute tourniquet occlusion time) the tourniquet will be applied for a period of 60 minutes and removed thereafter. This will be reapplied for another 60 minutes if deemed necessary by the surgeon after 60 seconds of release 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.​Symptomatic women with uterine fibroids who wish to preserve their uterus 2.​Age between 20 to 45 years 3. women with regular menstruation. 1.​Women less than 20 or over 45 years of age 2.​Use of Gonadotropin releasing hormone agonists or oral contraceptive in the past 3 months prior to recruitment. 3. History of use of phytoestrogen or herbal medication in the previous 3 months before recruitment 4. Women with clinical features of ovarian insufficiency 5.​Patients who were identified with any disease other than myoma (polycystic ovarian syndrome, endometriosis, tumor, etc.) during surgery 6. Association with adnexal tumors or previous adnexal surgery at the same time 7.​Positive pregnancy test Adult: 19 Year-44 Year 20 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 22/12/2022 Nnamdi Azikiwe University Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Old Onitsha road nnewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is mean difference in serum AMH before and after tourniquet application. Before and after surgery
Secondary Outcome The secondary outcome measure is mean serum AMH levels for different durations of tourniquet occlusion time. Post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria Old Onitsha road Nnewi Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Lambert Chukwu Onyejiaku Old Onitsha road Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Lambert Chukwu Onyejiaku Old Onitsha road nnewi Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Chima Henry Okpara Old Onitsha road Nnewi Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lambert Onyejiaku omekaonyejiaku@gmail.com +234706188351 Old Onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Specialist Registration Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Old Onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2348068117444 Old Onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form 1 year from onset of study Not applicable
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