Completed

NCT Number: NCT04969120

Metoclopramide and the Length of First Stage of Labor , 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.

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Key information

Conditions

Labour Duration and Metoclopramide

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics and gynecology department at kasralainy hospital

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide 10mg

Drug

this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses

Placebo (0.9 sodium chloride)

Drug

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

Primary outcomes

duration of labour

Time frame: 8-12 hours

cervical dilatation rate in first stage of labour

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jul 20, 2021
Registry last updated: Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.