跳至主要内容
临床试验/NCT05222646
NCT05222646Unknown1 期

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

Uwakwe Emmanuel Chijioke1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
150
试验地点
1
主要终点
Duration of first stage of labour

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Will receive 20 mg of Hyoscine bromide,

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All nullipara who gave consent

排除标准

  • those who refused consent

研究组 & 干预措施

Metoclopramide group

Active Comparator

They will be receiving10mg of Metoclopramide intramuscularly

干预措施: Metoclopramide (Drug)

Hyoscine bromide group

Active Comparator

They will be receiving 20 mg of Hyoscine bromide

干预措施: Metoclopramide (Drug)

结局指标

主要结局

Duration of first stage of labour

时间窗: 6 months

Duration of first stage of labour

次要结局

未报告次要终点

研究者

发起方
Uwakwe Emmanuel Chijioke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Uwakwe Emmanuel Chijioke

Principal Investigator

Alex Ekwueme Federal University Teaching Hospital

研究点 (1)

Loading locations...

相似试验