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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labour Duration and Metoclopramide

Intervention / Treatment
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* Drug: Metoclopramide 10mg
* Drug: Placebo (0.9 sodium chloride)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (group 1) receiving intravenous metoclorpramide<br>this group receive 10mg intravenous metoclopramide | Drug: Metoclopramide 10mg<br>* this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses<br>|
| Placebo Comparator: (group 2) receiving placebo<br>this group receive 10mg intravenous placebo(0.9 sodium chloride) | Drug: Placebo (0.9 sodium chloride)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of labour | cervical dilatation rate in first stage of labour | 8-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| labour pain | 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 | pain assessment at 30,60,120 minutes following injection of metoclopramide | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metoclopramide - labor duration-labor pain