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

Overview

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.

Full Title of Study: “The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 1, 2022

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Active Comparator: (group 1) receiving intravenous metoclorpramide
    • this group receive 10mg intravenous metoclopramide
  • Placebo Comparator: (group 2) receiving placebo
    • this group receive 10mg intravenous placebo(0.9 sodium chloride)

Clinical Trial Outcome Measures

Primary Measures

  • duration of labour
    • Time Frame: 8-12 hours
    • cervical dilatation rate in first stage of labour

Secondary Measures

  • labour pain
    • Time Frame: pain assessment at 30,60,120 minutes following injection of metoclopramide
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shaimaa Mostafa Mohammed Refaay El shemy, Lecturer of Obstetrics and gynecology at Cairo university – Cairo University

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