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.: PACTR202001579275333 Date of Approval: 24/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Premaquick Biomarkers versus Transvaginal Ultrasonographically Measured Cervical Length for Pre-Induction Cervical Assessment at Term: A Randomized Study
Official scientific title Combined Insulin-like Growth Factor Binding Protein-1 and Interleukin-6 versus Transvaginal Ultrasonographically Measured Cervical Length for Pre-induction Cervical Assessment at Term: A Randomized Study
Brief summary describing the background and objectives of the trial BACKGROUND: Bishop score since its introduction in 1964 is traditionally used to determine the inducibility of the cervix for cervical ripening and induction of labour. Bishop score is subjective and its associated with significant intra and inter observer variability. Other newer methods such as cervical length measurement using transvaginal ultrasonography, testing for the presence of phosphorylated insulin like growth factor binding protein-1, fetal fibronectin, interleukin-6 or their combination in cervico-vaginal fluid have been shown to be more objective and reproducible for preinduction of labour cervical evaluation at term. While several studies have either compared Bishop score and transvaginal ultrasound cervical length, or combined insulin-like growth factor binding protein-1 (IGFBP-1) and interleukin-6 (IL-6) versus Bishop score, no prior study to the best of the knowledge of the researcher has compared IGFBP-1 and IL-6 versus transvaginal ultrasonographically measured cervical length for pre induction cervical assessment at term. OBJETIVES:
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 pregnancy and delivery
Purpose of the trial Treatment: Drugs
Anticipated trial start date 27/01/2020
Actual trial start date 15/08/2020
Anticipated date of last follow up 27/04/2020
Actual Last follow-up date 15/02/2021
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
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
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Premaquick At start of cervical ripening and or at the start of induction of labour At the start of cervical ripening and or at start of induction of labour For the purpose of management of the patient, the patients who gave an informed consent will be randomized into the premaquick group or transvaginal ultrasound group as contained in the sealed opaque non transparent envelop. The premaquick will be provided by BIOSYNEX FRANCE (containing sterile copan flocked swab, tube containing 1ml of buffer solution and a cassette). the sterle swab will be introduced into the exposed posterior vaginal fornix to absorb cervicovaginal secretions/fluid for about 15 to 30 secs to allow for optimal absorption. The sterile swab will be removed and placed in the buffer solution and rotated for about 10 seconds. Two to three dropsdrops of the already mixed buffer solution with cervicovaginal secretions will be placed into each well of the three biomarkers(IGFBP-1 N, IGFBP-1 T & IL6) and the result will be interpreted and recorded in the patient's chart. The cassette has C and T letters that corresponds to Control and Test lines. Presence of three control lines (C) will be important for validation. The test will be said to be positive if 2 or 3 T lines of the biomarkers are present. Negative test will be when the three lines are absent or when there is presence of only one T line. Patients with negative test will be commenced on cervical ripening and induction of labour using 50microgram of intravaginal misoprostol and patients with positive test will be commenced on induction of labour using 10iu of oxytocin in 1litre of normal saline or 5% dextrose water at rate of 10 drops per mins according to NAUTH labour ward protocol and increased by 10 drops per minute every 30 mins until adequate uterine contractions of 3 to 5 contractions in 10 mins lasting for 40-60 secs. NB Bishop score will be done and documented in the patient's folder but for the purpose of the study, management of the patient will be based on either Premaquick biomarker findings or transvaginal cervical length measurement fok losing randomization. 36
Control Group Transvaginal ultrasound cervical length measurement At the start of cervical ripening and induction of labour Once at start of cervical ripening or induction of labour For patients that gave an informed consent to participate in the study and were randrandomized into the transvaginal ultrasound group. Preinduction cervical assessment will be done using transvaginal ultrasound cervical length measurement. Cervical length less than 28mm is considered to be ripe for induction of labour using 10iu of oxytocin in 1litre of normal saline or 5% dextrose water while cervical length of greater than or equal to 28mm will be considered unripe hence cervical ripening with 50microgram of intravaginal misoprostol according to NAUTH labour ward protocol will be done. The researcher and the patients will not be aware the group the patient belongs to hence double blind. NB. Modified Bishops score will be done for all patients and recorded in their folders but for the purpose of the study, management of the patient will be based on either Premaquick findings or Transvaginal ultrasound cervical length measurement following randomization as contained in the sealed opaque non transparent envelop. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Term (37-42weeks) singleton pregnancy 2. Primigravida or Nulliparous pregnant women 3. Cephalic presenting fetus 4. Presence of intact fetal membranes 5. No contraindications to vaginal delivery 1. Preterm pregnancy 2. Intra uterine fetal death 3. Cephalopelvic disproportion 4. Fetal abnormal lie 5. Fetal abnormal presentation 6. Multiple pregnancy 7. Previous caeserean scar or uterine surgeries 8. Preinduction fetal heart rate abnormalities Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 28/05/2019 NAUTH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NNEWI ONITSHA ROAD NNEWI 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Proportion of women who will need prostaglandin analogue for cervical ripening after preinduction cervical assessment by each method At the onset of commencement of cervical ripening
Primary Outcome 2. Proportion of women who will achieve vaginal delivery after induction of labour in each group At the time of delivery
Secondary Outcome 1. Mean induction to delivery interval in hours after induction of labour in each group At the time of delivery
Secondary Outcome 2. The proportion of women who will be delivered by caesarean section after induction of labour in each group At the time of delivery
Secondary Outcome 3. Mean total dose of prostaglandins administered for preinduction cervical ripening in each group At the time of induction of labour or transition into active labour
Secondary Outcome 4. Proportion of neonates with birth asphyxia with APGAR score less than 6 in 1st minute in each group At the time of delivery
Secondary Outcome 5. Proportion of neonates that will require admission into the New born special care baby unit in each group At the time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI NNEWI ONITSHA ROAD NNEWI Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
BIOSYNEX SA FRANCE CEDEX SRASBOURG France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR CHIGOZIE OKAFOR OTOLO NNEWI NNEWI Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR ERIC UMEH NNEWI ONITSHA ROAD NNEWI Nigeria
DR CHISOLUM OKAFOR NNEWI ONITSHA ROAD NNEWI Nigeria
DR UMEOKAFOR CHIJOKE NNEWI ONITSHA ROAD NNEWI Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHIGOZIE OKAFOR chygolz.co@gmai.com +2348034802657 OTOLO NNEWI
City Postal code Country Position/Affiliation
NNEWI Nigeria SENIOR SPECIALIST REGISTRAR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY NAUTH NNEWI
Role Name Email Phone Street address
Public Enquiries BRIAN ADINMA brianadinma@yahoo.com +2348037080814 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI Nigeria PROFESSOR OF OBSTETRICS AND GYNAECOLOGY NAUTH NNEWI
Role Name Email Phone Street address
Scientific Enquiries GEORGE ELEJE georgel21@yahoo.com +2348068117444 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI Nigeria SENIOR LECTURER AND CONSULTANT OBSTETRICS AND GYNAECOLOGY
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes To submit research proformo Study Protocol six months After six months
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