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

NCT ID: NCT04969120

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-07-01

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.

Conditions

Labour Duration and Metoclopramide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

(group 1) receiving intravenous metoclorpramide

this group receive 10mg intravenous metoclopramide

Group Type: ACTIVE_COMPARATOR

Metoclopramide 10mg

Intervention Type: DRUG

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

(group 2) receiving placebo

this group receive 10mg intravenous placebo(0.9 sodium chloride)

Group Type: PLACEBO_COMPARATOR

Placebo (0.9 sodium chloride)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mostafa Mohammed Refaay El shemy

Lecturer of Obstetrics and gynecology at Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Obstetrics and gynecology department at kasralainy hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Metoclopramide and labour

Identifier Type: -

Identifier Source: org_study_id