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

Phase 1

• Conditions: Duration of Labour
• Interventions: Drug: Metoclopramide

• Registration Number: NCT05222646
• Lead Sponsor: Uwakwe Emmanuel Chijioke

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

Study Timeline

• Study First Submitted: 2021-10-05
• Study Start: 2022-01-03
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. All nullipara who gave consent

Exclusion Criteria

1. those who refused consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyoscine bromide group	Metoclopramide	They will be receiving 20 mg of Hyoscine bromide
Metoclopramide group	Metoclopramide	They will be receiving10mg of Metoclopramide intramuscularly

Primary Outcome Measures

Name	Time	Method
Duration of first stage of labour	6 months	Duration of first stage of labour

Trial Locations

Locations (1)

AEFUTHA; 🇳🇬 Abakaliki, Ebonyi, Nigeria