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

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.

Study Overview

• Status: Completed
• Conditions: Prolonged First Stage of Labor
• Intervention / Treatment: Drug: Metoclopramide; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Khamis Mushait, Saudi Arabia, 101
    • Labor and delivery ward of Armed Forces Hospital, Southern Region.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cervical dilatation rate	6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of the first stage of labor	6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the second stage of labor		2 hours
Duration of the third stage of labor		1 hour
Number of Participants with Adverse Events	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)	24 hours
Apgar score		10 minutes
Meconium stained liquor		6 hours
Neonatal intensive care unit admission rate		24 hours
Rate of vaginal delivery		12 hours
Number of participants with genital tract injuries	genital tract injuries: Perineal tears; Vaginal tears; Cervical tears; Perineal hematomas; Vaginal hematomas; Uterine rupture	2 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Armed Forces Hospitals, Southern Region, Saudi Arabia
• Investigators: Study Director: Mohamed I Ellaithy, MD, ain shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 1, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: AFHSR-13-7-2013