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.: PACTR202101587114496 Date of Approval: 25/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RANDOMIZED CONTROL TRIAL ON THE SAFETY AND EFFICACY OF TRIANGULAR THREE BITES CERVICAL CERCLAGE VERSUS McDONALD TECHNIQUE IN IMPROVING PREGNANCY OUTCOME IN WOMEN WITH CERVICAL INSUFFICIENCY IN ANAMBRA STATE, NIGERIA
Official scientific title RANDOMIZED CONTROL TRIAL ON THE SAFETY AND EFFICACY OF TRIANGULAR THREE BITES CERVICAL CERCLAGE VERSUS McDONALD TECHNIQUE IN IMPROVING PREGNANCY OUTCOME IN WOMEN WITH CERVICAL INSUFFICIENCY IN ANAMBRA STATE, NIGERIA
Brief summary describing the background and objectives of the trial It is a prospective open labelled randomized controlled trial to compare the efficacy of novel triangular three bites cervical cerclage method to conventional McDonald method in a private multi-specialist hospital in Anambra State, Nigeria. The main objective isto compare the safety and efficacy of the triangular three bites cervical cerclage to conventional McDonald cervical cerclage (4-5 bites) method. Secondary objectives are as follow; 1. To compare the success rate of the two methods 2. To compare the length of time involved in performing the two methods 3. To compare the ease of performing the two methods 4. To compare the complications associated with the two methods 5. To compare the blood flow changes on doppler with the two methods
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LIFE TRAL 3
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 172
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 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
Experimental Group 3 bites cervical cerclage method once Cervical cerclage will be applied by new 3 bites technique, then both the main and secondary objectives will be assessed afterwards 86
Control Group McDonald method once Cervical cerclage will be applied by new McDonald technique, then both the main and secondary objectives will be assessed afterwards 86 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women with either history indicated, or ultrasound indicated cervical cerclage They will be willing and sign an informed consent for the procedure and study. Those not willing to participate in the study Those with any contra indication to vaginal cervical cerclage (active preterm labour, fetal demise, vaginal bleeding, preterm rupture of membrane, etc) Those for emergency cervical cerclage Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 23/12/2020 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Ethics committee
Ethics Committee Address
Street address City Postal code Country
Enugu-Onitsha express way Awka 420108 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The rate of preterm birth in both groups From the time of application to time of delivery
Secondary Outcome 1. The rate of term deliveries for the two methods 2. The length of time involved in performing the two methods 3. The degree of difficulty in performing the two methods 4. The complications associated with the two methods 5. The blood flow changes on doppler with the two methods From the time of application to the time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life international Hospital Zik avenue Awka 420108 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Joseph I Ikechebelu Department of OBGYN Nnamdi Azikiwe University Awka 420108 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor joseph I Ikechebelu Department of OBGYN Nnamdi Azikiwe University Awka 420108 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ngozi Joe Ikechebelu Department of Community Medicine, Chukwuemeka Odumegwu University Awka 420108 Nigeria
Cyril Nwachukwu Department of Anesthesia, Nnamdi Azikiwe University Awka 420108 Nigeria
Princeton okam Department of OBGYN, Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Louis Nwajiaku Life international hospital Awka 420108 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Ikechebelu ji.ikechebelu@unizik.edu.ng +2348034044189 Department of OBGYN nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420108 Nigeria Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Boniface Okpala bc.okpala@unizik.edu.ng +2348033204866 Department of OBGYN Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420108 Nigeria Scientific enquiries
Role Name Email Phone Street address
Public Enquiries George Eleje gu.eleje@unizik.edu.ng 2348068117444 Department of OBGYN, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420108 Nigeria Public Enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol six months following publication, No end date OPEN
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