Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial

The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial

Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being and for the providers of the birth services. Avoiding a long, protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the childbirth experience.

Prolonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.

Study Overview

• Status: Completed
• Conditions: Labour Duration and Metoclopramide
• Intervention / Treatment: Drug: Metoclopramide 10mg; Drug: Placebo (0.9 sodium chloride)

Detailed Description

Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.

Metoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.

Metoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.

The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Obstetrics and gynecology department at kasralainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primigravida
• singleton pregnancy
• termgestation (37-42 weeks)
• sure reliable dated
• vertex presentation , occipito-anterior position
• regular uterine contractions at every 5 minutes,each lasting for 20 seconds
• cervical dilatation of 5 cm
• with or without rupture of membrane
• no evidence of maternal or fetal distress

Exclusion Criteria:

• chorioamnionitis
• scarred uterus e.g. myomectomy
• cephalopelvic dispropotion
• history of cervical surgery or injury
• hypersensitivity to metoclopramide

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (group 1) receiving intravenous metoclorpramide; this group receive 10mg intravenous metoclopramide	Drug: Metoclopramide 10mg; this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses
Placebo Comparator: (group 2) receiving placebo; this group receive 10mg intravenous placebo(0.9 sodium chloride)	Drug: Placebo (0.9 sodium chloride); this group receive 10mg intravenous placebo(0.9 sodium chloride) slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of labour	cervical dilatation rate in first stage of labour	8-12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labour pain	effect of metoclopramide on labour pain score using visual analogue scale which is a score from 0 to 10 cm The higher the score represents more pain	pain assessment at 30,60,120 minutes following injection of metoclopramide

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Metoclopramide - labor duration-labor pain
• 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: Metoclopramide and labour

Drug and device information, study documents

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