NCT01937234

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 child birth experience. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

September 1, 2013

Last Update Submit

March 9, 2017

Conditions

Prolonged First Stage of Labor

Outcome Measures

Primary Outcomes (1)

  • Cervical dilatation rate

    6 hours

Secondary Outcomes (1)

  • Duration of the first stage of labor

    6 hours

Other Outcomes (8)

  • Duration of the second stage of labor

    2 hours

  • Duration of the third stage of labor

    1 hour

  • Number of Participants with Adverse Events

    24 hours

  • +5 more other outcomes

Study Arms (2)

Metoclopramide

ACTIVE COMPARATOR

Intravenous injection of 10mg metoclopramide

Drug: Metoclopramide

Placebo

PLACEBO COMPARATOR

Intravenous injection of 0.9% sodium chloride

Drug: Placebo

Interventions

MetoclopramideDRUG

Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours. Maximum of 3 doses.

Also known as: Primperan (Trademark)
Metoclopramide
PlaceboDRUG

Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours. Maximum of 3 doses.

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primigravida
  • Singleton pregnancy
  • Term gestation i.e. 37- 42 weeks
  • Sure reliable dates
  • Vertex presentation, occipitoanterior position
  • Spontaneous onset of labor
  • Regular uterine contractions at every 5 min ,each lasting for 20 sec
  • Cervical dilatation of 3-5cm
  • With or without rupture of membranes
  • No evidence of maternal or fetal distress

You may not qualify if:

  • Mal-presentations
  • Mal-positions
  • Multifetal pregnancy
  • Cephalopelvic disproportion
  • history of cervical surgery or injury
  • Hypersensitivity to metoclopramide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labor and delivery ward of Armed Forces Hospital, Southern Region.

Khamis Mushait, Khamis Mushait, 101, Saudi Arabia

Location

Related Publications (1)

  • Ellaithy M, Rasheed S, Shafik A, Abees S. Use of an antiemetic to shorten the length of labor in nulliparous women, exploring a potential role of an old drug: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):72-78. doi: 10.1002/ijgo.12998. Epub 2019 Nov 8.

    PMID: 31609464DERIVED

MeSH Terms

Interventions

MetoclopramidePatents as TopicSaline Solution

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsIntellectual PropertyJurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohamed I Ellaithy, MD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics & Gynecology

Study Record Dates

First Submitted

September 1, 2013

First Posted

September 9, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

SA(1)