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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04969120
Enrollment
80
Registered
2021-07-20
Start date
2022-03-01
Completion date
2022-07-01
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Duration and Metoclopramide

Keywords

Metoclopramide - labor duration-labor pain

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.

Interventions

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

DRUGPlacebo (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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
duration of labour8-12 hourscervical dilatation rate in first stage of labour

Secondary

MeasureTime frameDescription
labour painpain assessment at 30,60,120 minutes following injection of metoclopramideeffect 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026