Duration of LabourPhase 1NCT05222646
Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of First Stage of Labour
A Phase 1 study testing Metoclopramide in people with Duration of Labour, run by Uwakwe Emmanuel Chijioke at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Duration of Labour
- What is being tested?
- Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNigeria
- Study dates
- 3 Jan 2022to 30 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. All nullipara who gave consent
Who cannot join
- 1. those who refused consent
Trial locations and contacts
1 site in 1 country.
UWAKWE DR EMMANUEL CHIJIOKE, PART 1 contact
Nigeria1 site, 1 recruiting
- Recruiting
AEFUTHA
Abakaliki, Ebonyi State, 234
Uwakwe DR Emmanuel Chijioke, PART 1, 08068748644 ext. ABAKALIKI, darlingtonpeter2012@gmail.com
UGOJI DR DARLINGTON-PETER, PART 1, 08068748644 ext. ABAKALIKI, darlingtonpeter2012@gmail.com
About this study
Official title: Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of the First Stage of Labor Among Nulliparous Women in Abakaliki
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.
Read the detailed description
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.
OBJECTIVE This study is designed to compare the effectiveness of metoclopramide versus hyoscine butyl bromide in shortening the duration of the first stage of labour in Abakaliki.
Methods: This would be an equivalence randomized, double-blinded, placebo-controlled trial among nulliparous women in labour Abakaliki to determine the effectiveness of intramuscular Metoclopramide versus intramuscular Hyoscine bromide in shortening the duration of the first stage of labour. One arm will receive a single dose of 10mg of Metoclopramide intramuscularly, another will receive 20 mg of Hyoscine bromide, the third am will receive 1 ml of sterile water(placebo) intramuscularly. The data obtained will be analysed using Statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA) and the intention to treat the concept. Continuous variables would be presented as mean and standard deviation (Mean ± 2SD), while categorical variables would be presented as numbers and percentages. Logistic regression will also be applied where applicable. A difference with a P-value of ≤ 0.05 will be taken to be statistically significant.
Results: The results will be presented in tables from where conclusions will be drawn
CONCLUSION KEYWORD Prolonged labour, Metoclopramide, Hyoscine Bromide, the active phase of labour
- Conditions
- Duration of Labour
- Being tested
- Metoclopramide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Placebo
Will receive single dose of 10mg of Metoclopramide intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide group | Active comparator | They will be receiving10mg of Metoclopramide intramuscularly Receives: Drug: Metoclopramide |
| Hyoscine bromide group | Active comparator | They will be receiving 20 mg of Hyoscine bromide Receives: Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of first stage of labour
Duration of first stage of labour
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start3 Jan 2022
- Primary completion3 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of LabourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will receive single dose of 10mg of Metoclopramide intramuscularly
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uwakwe Emmanuel Chijioke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uwakwe Emmanuel Chijioke, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- Uwakwe DR Emmanuel Chijioke, PART 1, Principal investigator, Alex Ekwueme Federal University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222646
- Sponsor's protocol ID
- AEFUTHA/16/07/2020.4/11/2020
- Status last verified
- Feb 2022
- First submitted
- 5 Oct 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of the First Stage of Labor Among Nulliparous Women in Abakaliki
- ClinicalTrials.gov ID
- NCT05222646
- Acronym / sponsor ID
- AEFUTHA/16/07/2020.4/11/2020
- Conditions
- Duration of Labour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Uwakwe Emmanuel ChijiokeUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
OBJECTIVE This study is designed to compare the effectiveness of metoclopramide versus hyoscine butyl bromide in shortening the duration of the first stage of labour in Abakaliki.
Methods: This would be an equivalence randomized, double-blinded, placebo-controlled trial among nulliparous women in labour Abakaliki to determine the effectiveness of intramuscular Metoclopramide versus intramuscular Hyoscine bromide in shortening the duration of the first stage of labour. One arm will receive a single dose of 10mg of Metoclopramide intramuscularly, another will receive 20 mg of Hyoscine bromide, the third am will receive 1 ml of sterile water(placebo) intramuscularly. The data obtained will be analysed using Statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA) and the intention to treat the concept. Continuous variables would be presented as mean and standard deviation (Mean ± 2SD), while categorical variables would be presented as numbers and percentages. Logistic regression will also be applied where applicable. A difference with a P-value of ≤ 0.05 will be taken to be statistically significant.
Results: The results will be presented in tables from where conclusions will be drawn
CONCLUSION KEYWORD Prolonged labour, Metoclopramide, Hyoscine Bromide, the active phase of labour
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Will receive single dose of 10mg of Metoclopramide intramuscularly
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide group | Active comparator | Drug: MetoclopramideThey will be receiving10mg of Metoclopramide intramuscularly |
| Hyoscine bromide group | Active comparator | Drug: MetoclopramideThey will be receiving 20 mg of Hyoscine bromide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. All nullipara who gave consent
Key exclusion criteria (1 listed)
- 1. those who refused consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramideAlso: PlaceboWill receive single dose of 10mg of Metoclopramide intramuscularly | Drug | Hyoscine bromide group, Metoclopramide group |
Primary outcome
Duration of first stage of labour
Time frame: 6 months
Duration of first stage of labour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UWAKWE DR EMMANUEL CHIJIOKE, PART 1 contact
Uwakwe DR Emmanuel Chijioke, PART 1 principal investigator
Alex Ekwueme Federal University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metoclopramide in people with Duration of Labour, run by Uwakwe Emmanuel Chijioke at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UWAKWE DR EMMANUEL CHIJIOKE, PART 1 (0806 874 8644 ext. ABAKALILI, darlingtonpeter2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of first stage of labour (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.