Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women
Condition: Prolonged First Stage of Labor
Study type: Interventional
Phase: Phase 4

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.
    

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
    

Intervention name(s): Metoclopramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours.
Maximum of 3 doses.; Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours.
Maximum of 3 doses.
Other intervention name(s): Primperan (Trademark); Normal saline
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention