Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of First Stage of Labour
1 other identifier
interventional
150
1 country
1
Brief Summary
BACKGROUND Prolonged labour can lead to increased maternal and neonatal mortality and morbidity. The risk for complications of prolonged labour is more in poor resource settings. Active management of labour has been shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could also lead to faster and more effective dilatation of the cervix. As the evidence to support this is still largely anecdotal around the world, there is a need to conduct clinical trials so as to obtain a valid answer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedFebruary 3, 2022
February 1, 2022
7 months
October 5, 2021
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of first stage of labour
Duration of first stage of labour
6 months
Study Arms (2)
Metoclopramide group
ACTIVE COMPARATORThey will be receiving10mg of Metoclopramide intramuscularly
Hyoscine bromide group
ACTIVE COMPARATORThey will be receiving 20 mg of Hyoscine bromide
Interventions
Will receive single dose of 10mg of Metoclopramide intramuscularly
Eligibility Criteria
You may qualify if:
- \. All nullipara who gave consent
You may not qualify if:
- \. those who refused consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AEFUTHA
Abakaliki, Ebonyi State, 234, Nigeria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uwakwe DR Emmanuel Chijioke, PART 1
Alex Ekwueme Federal University Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Will receive 20 mg of Hyoscine bromide,
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 5, 2021
First Posted
February 3, 2022
Study Start
January 3, 2022
Primary Completion
August 3, 2022
Study Completion
August 30, 2022
Last Updated
February 3, 2022
Record last verified: 2022-02