Clinical trial NCT04969120: Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial
Official title: The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labour Duration and Metoclopramide
Keywords: Metoclopramide - labor duration-labor pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of labour
timeFrame: 8-12 hours
Secondary outcomes:
measure: labour pain
timeFrame: pain assessment at 30,60,120 minutes following injection of metoclopramide
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics and gynecology department at kasralainy hospital
Study officials:
References: