Clinical trial NCT05222646: Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of First Stage of Labour
Official title: Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of the First Stage of Labor Among Nulliparous Women in Abakaliki
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Duration of Labour
Lead sponsor: Alex Ekwueme Federal University Teaching Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Will receive single dose of 10mg of Metoclopramide intramuscularly
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

1. All nullipara who gave consent

Exclusion Criteria:

1. those who refused consent

Primary outcomes:
measure: Duration of first stage of labour
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: AEFUTHA
state: Ebonyi
Study officials:
affiliation: Alex Ekwueme Federal University Teaching Hospital
name: Uwakwe DR Emmanuel Chijioke, PART 1
role: PRINCIPAL_INVESTIGATOR
References: