Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
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.
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
Study:
NCT01937234
Study Brief:
Protocol Section:
NCT01937234