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Completed

NCT Number: NCT01937234

Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Khamis Mushait, 101, Saudi Arabia

About this study

Women who will fulfill the study inclusion and exclusion criteria and agree to be included in the study will be randomized assigned to receive either an intravenous injection of 10mg metoclopramide (Group 1) or the same volume of placebo, i.e. 0.9% sodium chloride (Group2). Randomization will be achieved using computer generated randomization sequences. Allocation will be in 1:1 ratio. Record of group allocation will be maintained by a resident physician whose responsibility is randomization and drawing up the injection, but has no direct involvement in the intrapartum decision making.

After through history and physical examination, each participant will take the selected medication slowly IV over 2 min, the assigned medication will be repeated every two hours for a maximum of three doses.

Monitoring of fetal well-being and labor progress with Partographic representation will be performed.

Management of labor will be according the labor and delivery standard protocol, if labor dilatation will not progress appropriately, i.e. cervical dilatation rate of <1cm/hour, amniotomy will be performed if membranes are intact. Oxytocin augmentation will be considered after rupture of membranes only if the cervix remains unchanged on two consecutive pelvic examination conducted two hours apart. Oxytocin infusion will start with 5mIU/min and increase by 5mIU/min every 15min to achieve seven contractions in 15 min, the maximal rate of oxytocin being 30Miu/min.

The following parameters will be recorded for every patient:

  • Timing of metoclopramide or placebo injections
  • Timing of full dilatation of cervix
  • Duration of first stage of labor
  • Duration of second stage of labor
  • Duration of third stage of labor
  • Mode of delivery
  • Injection to delivery interval
  • Cervical dilatation rate
  • Neonatal condition at birth

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Metoclopramide

Drug

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

Maximum of 3 doses.

Other names: Primperan (Trademark)

Placebo

Drug

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

Maximum of 3 doses.

Other names: Normal saline

Primary outcomes

  1. Cervical dilatation rate

    Time frame: 6 hours

Secondary outcomes

  1. Duration of the first stage of labor

    Time frame: 6 hours

Other outcomes

  1. Duration of the second stage of labor

    Time frame: 2 hours

  2. Duration of the third stage of labor

    Time frame: 1 hour

  3. Number of Participants with Adverse Events

    Time frame: 24 hours

    Adverse effects of metoclopramide:

    • Cardiovascular: heart block, bradycardia, heart failure, flushing, hyper or hypotension, supraventricular tachycardia.
    • Central nervous system: Drowsiness, acute dystonic reactions, headache, dizziness, akathisia, confusion, depression, hallucinations, Parkinsonian-like symptoms, suicidal ideation, seizure, tardive dyskinesia
    • Dermatologic: Angioneurotic edema, rash, urticaria
    • Gastrointestinal: Nausea, vomiting, diarrhea
    • Respiratory: Bronchospasm, laryngeal edema (rare), laryngospasm (rare)
  4. Apgar score

    Time frame: 10 minutes

  5. Meconium stained liquor

    Time frame: 6 hours

  6. Neonatal intensive care unit admission rate

    Time frame: 24 hours

  7. Rate of vaginal delivery

    Time frame: 12 hours

  8. Number of participants with genital tract injuries

    Time frame: 2 hours

    genital tract injuries:

    • Perineal tears
    • Vaginal tears
    • Cervical tears
    • Perineal hematomas
    • Vaginal hematomas
    • Uterine rupture

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Armed Forces Hospitals, Southern Region, Saudi Arabia

Registry information

Official study title

Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2013
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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