Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01937234
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Armed Forces Hospitals, Southern Region, Saudi Arabia
Information provided by (Responsible Party):
Mohamed Ellaithy, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Prolonged First Stage of Labor Drug: Metoclopramide Drug: Placebo Phase 4

Detailed Description:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug
Study Start Date : July 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metoclopramide
Intravenous injection of 10mg metoclopramide
Drug: Metoclopramide

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

Maximum of 3 doses.

Other Name: Primperan (Trademark)

Placebo Comparator: Placebo
Intravenous injection of 0.9% sodium chloride
Drug: Placebo

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

Maximum of 3 doses.

Other Name: Normal saline




Primary Outcome Measures :
  1. Cervical dilatation rate [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Duration of the first stage of labor [ Time Frame: 6 hours ]

Other Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937234


Locations
Layout table for location information
Saudi Arabia
Labor and delivery ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, Saudi Arabia, 101
Sponsors and Collaborators
Ain Shams University
Armed Forces Hospitals, Southern Region, Saudi Arabia
Investigators
Layout table for investigator information
Study Director: Mohamed I Ellaithy, MD Ain Shams University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mohamed Ellaithy, Lecturer of Obstetrics & Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT01937234     History of Changes
Other Study ID Numbers: AFHSR-13-7-2013
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action