Clinical trial NCT01937234: Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women
Official title: Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prolonged First Stage of Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2013-09-09
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Cervical dilatation rate
timeFrame: 6 hours
Secondary outcomes:
measure: Duration of the first stage of labor
timeFrame: 6 hours
Other outcomes:
measure: Duration of the second stage of labor
timeFrame: 2 hours
measure: Duration of the third stage of labor
timeFrame: 1 hour
measure: Number of Participants with Adverse Events
timeFrame: 24 hours
measure: Apgar score
timeFrame: 10 minutes
measure: Meconium stained liquor
timeFrame: 6 hours
measure: Neonatal intensive care unit admission rate
timeFrame: 24 hours
measure: Rate of vaginal delivery
timeFrame: 12 hours
measure: Number of participants with genital tract injuries
timeFrame: 2 hours
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Labor and delivery ward of Armed Forces Hospital, Southern Region.
Study officials:
affiliation: Ain Shams University
name: Mohamed I Ellaithy, MD
role: STUDY_DIRECTOR
References:
citation: Ellaithy M, Rasheed S, Shafik A, Abees S. Use of an antiemetic to shorten the length of labor in nulliparous women, exploring a potential role of an old drug: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):72-78. doi: 10.1002/ijgo.12998. Epub 2019 Nov 8.