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.: PACTR201604001592143 Date of Approval: 16/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Premaquick Pre-induction Cervical Assessmen Trial
Official scientific title Insulin-like growth factor binding protein-1(A and B)/interleukin-6 (Premaquick®) and Bishop score for pre-induction cervical assessment at term: a randomized control trial
Brief summary describing the background and objectives of the trial Introduction Induction of labor remains a common obstetric procedure with prostaglandins (misoprostol) commonly being used in our environment for pre-induction cervical ripening when the cervix is unfavorable. Cervical ripening and/or induction of labor artificially ripens the cervix and initiates uterine contractions in women who were not already in labor, leading to progressive dilation of the cervix to achieve vaginal birth of a baby at any gestation beyond the legal definition of fetal viability. In developed countries, one of every 4 babies is delivered after induction of labor at term and the rates are on the increase all over the world. Bishop score (now modified) remains the most frequently used and age-old method for selection of patients who should be treated with prostaglandins for cervical ripening. However, the assessment of cervical changes based on the Bishop score alone is subjective and the predictive value for failed induction in women with a low Bishop score is poor because of difficulty in assessing the change of the internal cervical os when the external cervical os is closed. Moreover, digital cervical examination is prone to large variations among examiners. A recent cochrane systematic review indicated that direct comparisons between Bishop score and other modalities (e.g. insulin-like growth factor binding protein-1 (IGFBP-1) and vaginal fetal fibronectin for assessing pre-induction cervical ripening among parturients at term gestations has yet to be carried out. This study aims to compare Insulin-like Growth Factor Binding Protein-1(A and B)/Interleukin-6 (Premaquick®, Biosynex SA, Strasbourg Cedex, France) and Bishop score in determining the need for administration of prostaglandin for preinduction cervical ripening among women with singleton gestations at term.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2016
Actual trial start date 01/09/2016
Anticipated date of last follow up 02/11/2016
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants) 151
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 randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Premaquick once Stat Participants who give informed consent will be enrolled in the study. All women will undergo cervical assessment by premaquick® and Bishop score, but clinical management of the women will be based on the result of randomized method only. Cervical assessment by premaquick® will be performed first and the person who assessed the cervix to make the clinical decision will be blinded to the results of 65
Control Group Bishop score once Stat Participants who give informed consent will be enrolled in the study. All women that were randomized to Bishop score method will undergo cervical assessment by Bishop score. Cervical assessment by premaquick® will be performed first and the person who assessed the cervix to make the clinical decision will be blinded to the results of premaquick®. We will use a modified Bishop score, which uses fi 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women scheduled for induction of labor at or beyond 37 weeks of gestation Singleton pregnancy Cephalic presentation Intact membranes Unfavourable cervix (Bishop score <6) Non-vertex presentation Uterine scars other than one prior low transverse cesarean section Multiple gestation Premature rupture of membranes. 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 02/04/2016 NAUTH ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Nnewi onitsha road nnewi nnewi 435001 Nigeria
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 25/07/2016 Nnamdi Azikiwe University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
nnewi Onitsha road Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome percentage of women with unripe cervix, i.e. the percentage of women who will be administered prostaglandin (misoprostol) as a preinduction agent At the stat of the intervention
Primary Outcome interval from start of induction to any type of delivery Time of start of recruitment Time of delivery
Primary Outcome Uterine rupture Time of delivery
Secondary Outcome Need for oxytocin augmentation Any time during the labour process
Secondary Outcome Interval from start of induction to beginning of active phase Time of induction Time of active phase
Secondary Outcome Number of women with spontaneous rupture of membranes and interval from start of induction to this event Time of start of intervention Time of spontaneous rupture of membranes
Secondary Outcome Route of delivery Time of delivery
Secondary Outcome Number of women with cesarean section for failed induction Time of delivery
Secondary Outcome Meconium passage Time of delivery
Secondary Outcome Birth weight Time of delivery
Secondary Outcome Apgar scores Time of delivery
Secondary Outcome Number of infants admitted to neonatal intensive care unit Time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital, Nnewi nnewi onisha road, nnewi nnewi 435001 Nigeria
University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu Enugu portharcourt road enugu Nigeria
Madonna University Teaching Hospital, Elele owerri prtharcourt road ELELE Nigeria
Anambra State University Teaching Hospital, Awka ONITSHA ENUGU ROAD AWKA Nigeria
Federal Medical Center, Umuahia ABA CALABA ROAD UMUAHIA Nigeria
Federal Teaching Hospital, Abakaliki Abakiliki enugu road Abakiliki Nigeria
ESUT Teaching Hospital, Parklane, Enugu Newmarket-GRA Road Enugu 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 GEORGE ELEJE NNEWI ONITSHA ROAD NNEWI 435001 Nigeria Charities/Societies/Foundation
Secondary Sponsor LIFE SPECIALIST HOSPITAL 49 IKEMBA DRIVE nnewi 435001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
DR GEORGE ELEJE nnewi onisha road, nnewi NNEWI 435001 Nigeria
DR EUZEBUS EZUGWU Enugu portharcourt road Enugu Nigeria
DR IFEANYICHUKWU EZEBIALU ONITSHA ENUGU ROAD AWKA Nigeria
DR NNABUIKE OJIEGBE ABA CALABAR ROAD UMUAHIA Nigeria
DR LEONARD AJAH Abakiliki enugu road Abakiliki Nigeria
DR CHUKWUDI OBIORA Newmarket-GRA Road Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEORGE ELEJE georgel21@yahoo.com +2348068117444 nnewi onitsha road
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria Nnamdi Azikiwe University Teaching Hospital, Nnewi
Role Name Email Phone Street address
Public Enquiries EUZEBUS EZUGWU ezugwueuzebus@yahoo.com +2348037020295 ENUGU-PH ROAD
City Postal code Country Position/Affiliation
ENUGU Nigeria University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu
Role Name Email Phone Street address
Scientific Enquiries JOSEPH IKECHEBELU jikechebelu@yahoo.com +2348034044189 49 IKEMBA DRIVE NNEWI
City Postal code Country Position/Affiliation
nnewi 435001 Nigeria Nnamdi Azikiwe University Teaching Hospital, Nnewi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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