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

NCT04969120 | Completed Phase 4

• 1 other identifier: Metoclopramide and labour
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Labour Duration and Metoclopramide

Keywords

Metoclopramide - labor duration-labor pain

Outcome Measures

Primary Outcomes (1)

• duration of labour

  cervical dilatation rate in first stage of labour

  8-12 hours

Secondary Outcomes (1)

• labour pain

  pain assessment at 30,60,120 minutes following injection of metoclopramide

Study Arms (2)

(group 1) receiving intravenous metoclorpramide

ACTIVE COMPARATOR

this group receive 10mg intravenous metoclopramide

Drug: Metoclopramide 10mg

(group 2) receiving placebo

PLACEBO COMPARATOR

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

Drug: Placebo (0.9 sodium chloride)

Interventions

Metoclopramide 10mg 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 1) receiving intravenous metoclorpramide

Placebo (0.9 sodium chloride) 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

(group 2) receiving placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• chorioamnionitis
• scarred uterus e.g. myomectomy
• cephalopelvic dispropotion
• history of cervical surgery or injury
• hypersensitivity to metoclopramide

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Obstetrics and gynecology department at kasralainy hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Metoclopramide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and gynecology at Cairo university

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 20, 2021
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

EG (1)