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.: PACTR202308710880623 Date of Approval: 01/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of the effect of intravenous dexamethasone use on pre-induction cervical parameters and induction of labour outcomes:a randomized controlled study.
Official scientific title Assessment of the effect of intravenous dexamethasone use on pre-induction cervical parameters and induction of labour outcomes:a randomized controlled study.
Brief summary describing the background and objectives of the trial The Obstetrician have to induce labour for various obstetric reasons, thus making induction of labour one of the commonly practiced contemporary obstetric interventions. Induction of labour (IOL) is most often conducted to mitigate perinatal mortality and improve maternal and perinatal outcomes. A well ‘primed’ cervix increases the success rate of achieving vagina delivery with positive materno-foetal outcomes. An appropriately scheduled and successful IOL enhances maternal and perinatal outcomes. This study is proposed to assess the role of dexamethasone in improving Bishop score before commencement of IOL and other effects on labour progress as well as materno-foetal outcomes. Objective: To evaluate the use of dexamethasone in IOL as it pertains to Pre-IOL cervical changes, duration of labour progress and labour outcomes. To further extend already existing knowledge on the use of dexamethasone in obstetric practice and conduction of IOL in UBTH, a tertiary hospital in Nigeria, West- Africa.
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 Induction of labour
Purpose of the trial Evaluation of the role of dexamethasone use in induction of labour and labour outcomes
Anticipated trial start date 01/08/2023
Actual trial start date
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
148301137 Health Research Ethics Committee, University of Benin Teaching Hospital, Edo state, Nigeria.
University of Benin Teaching Hospital, Edo state, Nigeria
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 randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamethasone sodium phosphate 8mg (2ml) of dexamethasone given intravenously as a single dose Start dose given when consenting participants present for cervical ripening in the Labour ward Following sampling which will be done using a computer-generated random distribution technique, blinding will be ensured in both the team members and participants during treatment allocation. When consenting nulliparous women who present to the labour ward for cervical ripening are allotted computer- generated numbers according to their order of presentation, allotted numbers haven been assigned treatment allocation which has been also been coded and with Pharmacist-on-duty. The sampling number is sent to the Pharmacist-on-duty who prepares the treatment (intervention or placebo) in a 2 millilitre syringe. Dexamethasone and sterile water are clear fluids, the contents of the prepared 2 millilitre syringe is unknown to team members and participants, this prepared treatment is sent to team member for administration. After passing intracervical exxtramniotic Foley catheter, the 2mls of intervention medication (8mg dexamethasone)is injected intravenously. Participants are then sent to lying ward and examined after 12hours. 54
Control Group Placebo Single dose of 2mls of placebo(sterile water) Start dose given as a single dose Following sampling which will be done using a computer-generated random distribution technique, blinding will be ensured in both the team members and participants during treatment allocation. When consenting nulliparous women who present to the labour ward for cervical ripening are allotted computer- generated numbers according to their order of presentation, allotted numbers haven been assigned treatment allocation which has been also been coded and with Pharmacist-on-duty. The sampling number is sent to the Pharmacist-on-duty who prepares the treatment (intervention or placebo) in a 2 millilitre syringe. Dexamethasone and sterile water are clear fluids, the contents of the prepared 2 millilitre syringe is unknown to team members and participants, this prepared treatment is sent to team member for administration. After passing intracervical exxtramniotic Foley catheter, the 2mls of placebo is injected intravenously. Participants are then sent to lying ward and examined after 12hours 54 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparity Gestational age of pregnancy of 39 to 42 weeks Unfavourable Bishop score of less than 6 Singleton pregnancy Cephalic presenting fetus Normal amniotic fluid Reassuring cardiotocograph No congenital foetal anomaly Maternal medical conditions example, hypertension, preeclampsia, hyperglyaemic states Fetal macrosomia Multiple gestation Breech presentation of foetus History of rupture of membranes Previous uterine surgery, previous caesarean section Women who do not give consent Women with favourable Bishop score of more than 6 Adult: 19 Year-44 Year 19 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 14/06/2023 University of Benin Teaching Hospital Health and Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ugbowo Lagos Road Benin City P.M.B1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in Bishop score following ripening and duration between the onset of induction of labour (IOL) to attainment of 4cm cervical dilatation or more. 12 hours following intravenous dexamethasone injection and duration between onset of IOL and attainment of active phase of labour.
Secondary Outcome Duration from onset of IOL to full cervical dilatation, duration of second and third stages of labour, Apgar score, meconium stained liquor, maternal blood pressure postpartum, maternal random blood sugar levels, presence of postpartum haemorrhage, neonatal intensive care unit admission. Intrapartum and postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF BENIN TEACHING HOSPITAL OBSTETRICS AND GYNAECOLOGY DEPARTMENT Ugbowo Lagos Road Benin city P.M.B1111 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oyenmwen Amadasun Ugbowo Lagos Road Benin City PMB1111 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oyenmwen Amadasun Ugbowo Lagos Road Benin City PMB1111 Nigeria Self sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oyenmwen Amadasun deobenz@yahoo.co.uk +2348065340818 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Resident Doctor Department of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Oyenmwen Amadasun deobenz@yahoo.co.uk +2348065340818 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Oyenmwen Amadasun deobenz@yahoo.co.uk +2348065340818 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City Nigeria Senior Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, participants data that underlie the results reported in the study after deidentification (text, tables, figures and appendices). Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who have interest in labour and induction of labour management, and provide a methodologically sound proposal. Access and data can be requested after data access agreement at third party site info@ubth.org
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