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

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.

Study Overview

• Status: Recruiting
• Conditions: Duration of Labour
• Intervention / Treatment: Drug: Metoclopramide

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: UWAKWE DR EMMANUEL CHIJIOKE, PART 1; Phone Number: ABAKALILI 0806 874 8644; Email: darlingtonpeter2012@gmail.com
• Study Contact Backup: Name: UGOJI DR DARLINGTON-PETER, PART 1; Phone Number: AEFUTHA 0806 874 8644; Email: darlingtonpeter2012@gmail.com

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 234
      • Recruiting
      • AEFUTHA
      • Contact: Uwakwe DR Emmanuel Chijioke, PART 1; Phone Number: ABAKALIKI 08068748644; Email: darlingtonpeter2012@gmail.com
      • Contact: UGOJI DR DARLINGTON-PETER, PART 1; Phone Number: ABAKALIKI 08068748644; Email: darlingtonpeter2012@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. All nullipara who gave consent

Exclusion Criteria:

1. those who refused consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metoclopramide group; They will be receiving10mg of Metoclopramide intramuscularly	Drug: Metoclopramide; Will receive single dose of 10mg of Metoclopramide intramuscularly; Other Names: Placebo
Active Comparator: Hyoscine bromide group; They will be receiving 20 mg of Hyoscine bromide	Drug: Metoclopramide; Will receive single dose of 10mg of Metoclopramide intramuscularly; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of first stage of labour	Duration of first stage of labour	6 months

Collaborators and Investigators

• Sponsor: Uwakwe Emmanuel Chijioke
• Investigators: Principal Investigator: Uwakwe DR Emmanuel Chijioke, PART 1, Alex Ekwueme Federal University Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Anticipated): August 3, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: AEFUTHA/16/07/2020.4/11/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No