Trial | NCT01937234  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    250
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.
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
Study Started
Jul 31
2013
Primary Completion
Jul 31
2016
Study Completion
Sep 30
2016
Last Update
Mar 10
2017

Drug Metoclopramide

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

  • Other names: Primperan (Trademark)

Drug Placebo

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

  • Other names: Normal saline

Metoclopramide Active Comparator

Intravenous injection of 10mg metoclopramide

Placebo Placebo Comparator

Intravenous injection of 0.9% sodium chloride

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
No Results Posted