Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of First Stage of Labour

NCT ID: NCT05222646

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-08-30

Brief Summary

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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

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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

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Duration of Labour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Will receive single dose of 10mg of Metoclopramide intramuscularly
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Will receive 20 mg of Hyoscine bromide,

Study Groups

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Metoclopramide group

They will be receiving10mg of Metoclopramide intramuscularly

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

Will receive single dose of 10mg of Metoclopramide intramuscularly

Hyoscine bromide group

They will be receiving 20 mg of Hyoscine bromide

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

Will receive single dose of 10mg of Metoclopramide intramuscularly

Interventions

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Metoclopramide

Will receive single dose of 10mg of Metoclopramide intramuscularly

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

1\. All nullipara who gave consent

Exclusion Criteria

1\. those who refused consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uwakwe Emmanuel Chijioke

OTHER

Sponsor Role lead

Responsible Party

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Uwakwe Emmanuel Chijioke

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Uwakwe DR Emmanuel Chijioke, PART 1

Role: PRINCIPAL_INVESTIGATOR

Alex Ekwueme Federal University Teaching Hospital

Locations

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AEFUTHA

Abakaliki, Ebonyi State, Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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UWAKWE DR EMMANUEL CHIJIOKE, PART 1

Role: CONTACT

0806 874 8644 ext. ABAKALILI

UGOJI DR DARLINGTON-PETER, PART 1

Role: CONTACT

0806 874 8644 ext. AEFUTHA

Facility Contacts

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Uwakwe DR Emmanuel Chijioke, PART 1

Role: primary

08068748644 ext. ABAKALIKI

UGOJI DR DARLINGTON-PETER, PART 1

Role: backup

08068748644 ext. ABAKALIKI

Other Identifiers

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AEFUTHA/16/07/2020.4/11/2020

Identifier Type: -

Identifier Source: org_study_id

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