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.: PACTR202002551739914 Date of Approval: 11/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transvaginal ultrasonographically measured cervical length versus Bishop score for pre-induction cervical assessment at term. A randomized study
Official scientific title Transvaginal ultrasonographically measured cervical length versus Bishop score for pre-induction cervical assessment at term. A randomized study.
Brief summary describing the background and objectives of the trial BACKGROUND: Assessment of cervical status is key to determining the inducibility of the cervix for vaginal delivery. Traditionally Bishops score has been used to predict the success of induction of labour. However, Bishop score is subjective, observer-dependent and not reproducible, hence newer modality like transvaginal ultrasound measurement of cervical length at term has been shown to eliminate the shortcomings of Bishops score in predicting the success of induction of labour. However, the use of cervical length for pre-induction cervical assessment to identify women that will benefit from pre-induction cervical ripening is not sufficiently implemented and none of such studies have been published in Nigeria. AIM: The study aims to compare transvaginal ultrasonographically measured cervical length versus Bishops score for pre-induction cervical assessment at term. OBJECTIVES: To compare the induction to active phase of labour interval, induction delivery interval, vaginal delivery rate, caeserean delivery rate due to failed induction when pre-induction cervical assessment was done using transvaginal ultrasonographically measured cervical length and Bishops score.
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 17/02/2020
Actual trial start date 03/03/2020
Anticipated date of last follow up 17/05/2020
Actual Last follow-up date 31/07/2020
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transvaginal ultrasound measurement of cervical length for preinduction cervical assessment At start of cervical ripening and or induction of labour Before commencement of cervical ripening Pregnant women that gave an informed consent will be enrolled into the study. Pregnant women randomized to Transvaginal ultrasound group will have cervical assessment by transvaginal measurement of cervical length and Bishop score but clinical decision on patient management will be based on the result of transvaginal ultrasound measurement of cervical length. Transvaginal ultrasound measurement of cervical length will be performed first and the doctor who evaluated the cervix to make clinical decision on management of the patient by transvaginal ultrasound measurement of cervical length will be blinded to the result of the Bishop score.Transvaginal ultrasound measurement of cervical length for preinduction cervical assessment will be done for those patients that belong to Transvaginal ultrasound group as contained in the sealed opaque envelopes and patient managed based on the cervical length. cervical length less than 28mm is considered to be ripe for induction of labour with 10iu of oxytocin in 1 litre of normal saline or 5% dextrose water according to NAUTH labour ward protocol for oxytocin induction of labour while cervical length greater than or equal to 28mm will be considered unripe hence the need for cervical ripening using 50microgram of misoprostol (pfizer brand) according to NAUTH labour ward protocol for cervical ripening using misoprostol. In this group, clinical management of the patient will be based on the cervical length measurement. 36
Control Group Bishop score for preinduction cervical assessment At start of cervical ripening and or at the start of induction of labour At commencement of cervical ripening and or at the start of induction of labour Pregnant women who gave an informed consent will participate in the study. All pregnant women that were randomized into the Bishop score group as contained in the sealed opaque non transparent envelop will have cervical evaluation by Bishop score. Cervical assessment by transvaginal ultrasound measurement of cervical length will be performed first and the doctor who assessed the cervix to take clinical decision on the patient management will be blinded to the result of transvaginal ultrasound measurement of cervical length Modified Bishop score will be done which consist of 5 parameters namely position of the cervix, consistency of the cervix, cervical length (effacement), cervical dilatation and station of the presenting part. The position of the cervix and consistency of the cervix have a score of 0 to 2 respectively while the cervical length, dilatation and station have a score of 0 to 3 respectively. Modified Bishop score has a total of 13. Score of less than 6 is considered unripe cervix hence the need for cervical ripening using 50 microgram of misoprostol(Pfizer brand) according to NAUTH labour ward protocol for cervical ripening using misoprostol. Score of greater than or equal to 6 is considered ripe for induction of labour using 10iu of oxytocin in 1 litre of normal saline or 5% dextrose water according to NAUTH labour ward protocol for oxytocin augumentation. Clinical management of patient in this group is based on the result of Modified Bishop score. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Gestational age of 37-42 weeks. 2. Singleton pregnancy. 3. Primigravida/nulliparous pregnant women. 4. Normotensive pregnancy. 5. Live cephalic presenting foetus. 6. Intact fetal membranes. 7. No evidence of labour. 8. No previous uterine surgeries/scar. 1. Women that refused to give consent for participation in the study. 2. Preterm pregnancices. 3. Non-cephalic presentation/foetal malpresentations. 4. Multiple pregnancies. 5. Women with previous uterine surgeries/scars. 6. Intrauterine fetal death. 7. Fetal heart rate abnormalities at the time of admission. 8. Those with contraindication to vaginal delivery. 9. Present history of antepartum haemorrhage. Adult: 19 Year-44 Year 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 03/01/2019 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. Mode of delivery. 2. Total amount of prostaglandins to be administered for pre-induction cervical assessment. At delivery.
Secondary Outcome 1. Proportion of women that were administered prostaglandins for pre-induction cervical priming due to unfavourable cervix. 2. The need for oxytocin augumentation. 3. Induction to active phase of labour interval. 4. Induction delivery interval. 5. APGAR Score and proportion of newborns admitted to Special Care Baby Unit. At delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi onitsha road Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR OKAFOR CHIGOZIE GEOFFREY DEPARTMENT OF OBSTETRICS AND GYNECOLOGY NAUTH NNEWI ONITSHA ROAD NNEWI 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Chigozie Okafor NAUTH Nnewi Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Okafor Chisolum NAUTH Nnewi. Nnewi 435101 Nigeria
Dr. Umeh Eric NAUTH Nnewi Nnewi 435101 Nigeria
Dr. Umeokafor Chijioke NAUTH Nnewi Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chigozie Okafor chygolz.co@gmail.com +2348034802657 NAUTH Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Registrar in the Department of Obstetrics and Gynaecology NAUTH Nnewi.
Role Name Email Phone Street address
Scientific Enquiries George Eleje george21@yahoo.com +2348068117444 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Senior Lecturer at Nnamdi Azikiwe University Teaching Hospital Nnewi.
Role Name Email Phone Street address
Public Enquiries Joseph Ikechebelu jikechebelu@yahoo.com +2348034044189 49, Ikemba Drive, Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Professor of Obstetrics and Gynaecology at Nnamdi Azikiwe University Teaching Hospital Nnewi.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Research proforma Informed Consent Form After 6 months At the end of the work
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