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.: PACTR202207540193379 Date of Approval: 25/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Iyiola A. trial
Official scientific title EFFECTS OF INTRAVENOUS METOCLOPRAMIDE ON THE PROGRESS OF ACTIVE PHASE OF LABOUR AMONG NULLIPAROUS PARTURIENTS: A DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial Abstract Background: Prolonged first stage of labour has been shown to be associated with increased risk of maternal and neonatal morbidities. Avoiding prolonged labour entails shorter exposure to pain, anxiety and stress. This would translate into improvement in maternal satisfaction with childbirth experience. Therefore, reducing the duration of labour is a highly desirable goal of intrapartum care, from a perspective of maternal and fetal wellbeing. Studies on the role of antispasmodics to prevent prolonged labour are research priority. There are conflicting reports on the role of existing antispasmodics. There is a resurgence in the use of metoclopramide as a shortening agent for labour, but literature is scanty on its role on labour progress. AIM: To determine the effect of intravenous metoclopramide given during labour in reducing duration of active phase of first stage of labour among nulliparous women. Objectives: To compare the mean duration of first, second and third stage of labour, to compare maternal and neonatal outcome between metoclopramide and control group and to determine the side effects of metoclopramide in parturient.
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 01/08/2022
Actual trial start date
Anticipated date of last follow up 18/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
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
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Single dose of intravenous 2mls of 0.9% normal saline given at 4 cm or 5 cm cervical dilatation Single dose Nulliparous parturient at active phase of labour ( 4 cm or 5 cm cervical dilatation) will be given a stat dose of 2ml of intravenous 0.9% normal saline as placebo 70 Placebo
Experimental Group Intravenous metoclopramide Single dose of 2ml intravenous metoclopramide Single dose Nulliparous parturient at active phase labor ( 4cm or 5 cm cervical dilatation) will be given single dose of 2ml of intravenous metoclopramide 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women who give informed consent • Age of 18 years or older • Nulliparity • Spontaneous onset of labour with cervical dilatation of 4 cm to 5cm • Singleton term gestation ( ≥ 37 weeks of gestation) • A live fetus with cephalic presentation. • Previous uterine scar • Those with any contraindication to vaginal delivery • Multiple gestation • Spontaneous rupture of membrane before presentation • Hypersensitivity to metoclopramide • Those with medical illness like hypertension, diabetes. Adult: 19 Year-44 Year 18 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 23/03/2021 Research and ethics committee Federal Meidcal centre Asaba
Ethics Committee Address
Street address City Postal code Country
Nnebisi road, Asaba Delta state Asaba 320213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measures will be rate of cervical dilatation per hour and duration of active first stage labour Time interval between active phase of labour, 4 cm or 5 cm cervical dilatation, and delivery
Secondary Outcome Secondary outcome measures will include duration of second and third stages of labour, intrapartum blood loss, proportion of parturient that required oxytocin augmentation, proportion of parturient that received analgesics and number of times received, APGAR scores at one and five minutes and major maternal drug adverse effects (dystonia, extrapyramidal manifestations, hallucination, visual disturbance, hypersensitivity reaction and skin rash). secondary outcome measures will be determined at birth, adverse drug effects will be assessed after drugs administration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Asaba Nnebisi road Asaba 320213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Iyiola Akeem Adewale No 17, Lady Stella Oghoro Street, Off DLA, Asaba Asaba Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Iyiola Akeem Adewale No 17, Lady Stella Oghoro street, off DLA, Asaba Delta state Asaba 320233 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr George U. Eleje Nnewichi, Nnwei Nnewi 435101 Nigeria
Dr Angela Uduak Ochei Okpanam road, Asaba Asaba 320242 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akeem Iyiola hackymzone@yahoo.com +2348035316831 Lady Stella Oghoro DLA, Asaba
City Postal code Country Position/Affiliation
Asaba Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Akeem Iyiola hackymzone@yahoo.com +2348035316831 Lady Stella Oghoro, DLA, Asaba
City Postal code Country Position/Affiliation
Asaba Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries George Eleje gu.eleje@unizik.edu.ng +2348068117444 Nnewichi, Nnewi
City Postal code Country Position/Affiliation
Nnewi Nigeria Associate Professor of Obstetrics and Gynaecology and Consultant Obstetrican and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after de-identification Informed Consent Form,Statistical Analysis Plan,Study Protocol December 2022 to February 2023 open
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