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

Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of the First Stage of Labor Among Nulliparous Women in Abakaliki

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05222646
Enrollment
150
Registered
2022-02-03
Start date
2022-01-03
Completion date
2022-08-30
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duration of Labour

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.

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

Interventions

DRUGMetoclopramide

Will receive single dose of 10mg of Metoclopramide intramuscularly

Sponsors

Uwakwe Emmanuel Chijioke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Will receive 20 mg of Hyoscine bromide,

Intervention model description

Will receive single dose of 10mg of Metoclopramide intramuscularly

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1\. All nullipara who gave consent

Exclusion criteria

1\. those who refused consent

Design outcomes

Primary

MeasureTime frameDescription
Duration of first stage of labour6 monthsDuration of first stage of labour

Countries

Nigeria

Contacts

Primary ContactUWAKWE DR EMMANUEL CHIJIOKE, PART 1
darlingtonpeter2012@gmail.com0806 874 8644
Backup ContactUGOJI DR DARLINGTON-PETER, PART 1
darlingtonpeter2012@gmail.com0806 874 8644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026