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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Labour Duration and Metoclopramide

Treatments: Drug: Placebo (0.9 sodium chloride); Drug: Metoclopramide 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04969120

Metoclopramide and labour

Details and patient eligibility

About

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 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.

Enrollment: 80 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

(group 1) receiving intravenous metoclorpramide

Active Comparator group

Description:

this group receive 10mg intravenous metoclopramide

Treatment:

Drug: Metoclopramide 10mg

(group 2) receiving placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (0.9 sodium chloride)