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.: PACTR202401879224913 Date of Approval: 09/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Metoclopramide on the duration of spontaneous active phase of labor in primigravid women at the Jos University Teaching Hospital; a randomized, double blind, placebo controlled trial
Official scientific title Effect of Metoclopramide on the duration of spontaneous active phase of labor in primigravid women at the Jos University Teaching Hospital; a randomized, double blind, placebo controlled trial
Brief summary describing the background and objectives of the trial Background: Prolonged labour is fraught with significant maternal and foetal risks which could manifest as foetal distress, birth asphyxia, maternal exhaustion, postpartum haemorrhage and overwhelming infection. This is why over the years, both pharmacological and non pharmacological interventions have been explored with the aim of speeding up the rate of cervical dilatation and shortening the duration of labour. Aside well established knowledge of the value of metoclopramide in the treatment of nausea, vomiting and gastro-oesophageal reflux, the drug is widely used in several hospitals in Egypt and the Middle East based on the assumption that it accelerates the first stage of labour. This practice has persisted even in the absence of solid evidence-based studies lending credibility to such action. Objective: To determine the effect of Metoclopramide on the duration of active phase labour in primigravid women as compared to a control group.
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 Labour
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/12/2023
Actual trial start date
Anticipated date of last follow up 21/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline Two doses of 2mls of normal saline given four hours apart Four hours 10 milligrams of metoclopramide is given to randomly selected participants intravenously once the diagnosis of active phase of labor is made. A repeat dose is administered four hours later while monitoring of maternal and fetal vital signs is ensured. 2mls of Normal saline will be used as placebo and will be given to participants in the control group who will be randomly selected as well. Cervical assessment is also done and findings documented with the ultimate aim of determining if metoclopramide significantly enhances cervical dilatation thereby shortening the duration of labour 44 Placebo
Experimental Group Metoclopramide 2 doses of 10mg metoclopramide given 4 hours apart four hours 2 doses of 10mg metoclopramide will be given parenterally four hours apart to randomly selected participants while administering 2mls of placebo (normal saline) to an equal number of randomly selected participants 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Primigravidae at term with singleton pregnancy 2. Primigravidae at term with spontaneous onset of labour and foetus in longitudinal lie and cephalic presentation 3. Primigravidae at term with cervical os dilatation of 4cm 4. Primigravidae meeting the above criteria who give consent to be included in the study 1. Women who have had a previous delivery 2. Women who have progressed beyond 4cm cervical os dilatation 3. Women with any contraindication to vaginal delivery 4. Women with abnormal presentations, multiple pregnancies, cephalo-pelvic disproportion, maternal obesity, short stature or medical disorder in pregnancy 5. Women with previous uterine scars 6. Women with previous adverse drug reaction to metoclopramide or with contraindication to metoclopramide 7. Women taking medications with drug interaction to metoclopramide 8. Women presenting preterm in labour Adult: 19 Year-44 Year 19 Year(s) 44 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 03/07/2023 JUTH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Katon Rikkos, Jos East Jos 930105 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures will include the total duration of the first, second and third stages of labor and cervical dilatation rate Attainment of full cervical dilatation, delivery of the infant and then delivery of the placenta
Secondary Outcome Need for oxytocin augmentation, delivery route, clinical maternal side effects (particularly tardive dyskinesia, drowsiness, restlessness, breast enlargement, low mood, diarrhoea, and urinary incontinence), perineal tears and postpartum blood loss. Other secondary outcomes include APGAR scores at minute one and five after birth as well as neonatal intensive care unit admission rates. During labor, in the immediate postpartum period and up until 48 hours post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Katon Rikkos Jos East 930105 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Caleb Kenechukwu Michael katon rikkos Jos east 930241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jos University teaching Hospital Katon Rikkos Jos East 930241 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caleb Kenechukwu Michael kaceyoha@gmail.com +2348065412541 Katon Rikkos
City Postal code Country Position/Affiliation
Jos 930241 Nigeria Senior Resident Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Charles Anyaka charlesanyaka@yahoo.com +2348037018988 Katon Rikkos
City Postal code Country Position/Affiliation
Jos 930241 Nigeria Consultant Obstetrician and Gynecologist
Role Name Email Phone Street address
Scientific Enquiries Francis Ajang Magaji magajif@unijos.edu.ng +2348037008730 katon Rikkos
City Postal code Country Position/Affiliation
Jos 930241 Nigeria Associate Professor of Obstetrics and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. This will include all of the individual participant data collected during the trial, after deidentification as well as study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code. This data will be made available immediately following publication with no end date and with anyone who wishes to access the data. The data will be made available on request for any purpose and could be accessed through the link; https://www.ajol.info/index.php/jjm Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be made available immediately following publication with no end date IPD will be made available to anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.ajol.info/index.php/jjm 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