Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women

Prolonged First Stage of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937234
• Other study ID #: AFHSR-13-7-2013
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2013
• Last updated: March 9, 2017
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolonged First Stage of Labor

Intervention

Drug:
• Metoclopramide
Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours. Maximum of 3 doses.
• Placebo
Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours. Maximum of 3 doses.

Locations

Country	Name	City	State
Saudi Arabia	Labor and delivery ward of Armed Forces Hospital, Southern Region.	Khamis Mushait

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Armed Forces Hospital, Southern Region, Khamis Mushayt, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of the second stage of labor		2 hours
Other	Duration of the third stage of labor		1 hour
Other	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
Other	Apgar score		10 minutes
Other	Meconium stained liquor		6 hours
Other	Neonatal intensive care unit admission rate		24 hours
Other	Rate of vaginal delivery		12 hours
Other	Number of participants with genital tract injuries	genital tract injuries: Perineal tears; Vaginal tears; Cervical tears; Perineal hematomas; Vaginal hematomas; Uterine rupture	2 hours
Primary	Cervical dilatation rate		6 hours
Secondary	Duration of the first stage of labor		6 hours