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

NCT ID: NCT01937234

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-09-30

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

Conditions

Prolonged First Stage of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Metoclopramide

Intravenous injection of 10mg metoclopramide

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

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

Maximum of 3 doses.

Placebo

Intravenous injection of 0.9% sodium chloride

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Maximum of 3 doses.

Interventions

Metoclopramide

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

Maximum of 3 doses.

Intervention Type: DRUG

Placebo

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

Maximum of 3 doses.

Intervention Type: DRUG

Other Intervention Names

Primperan (Trademark); Normal saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Armed Forces Hospitals, Southern Region, Saudi Arabia

OTHER_GOV

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ellaithy

Lecturer of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed I Ellaithy, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Labor and delivery ward of Armed Forces Hospital, Southern Region.

Khamis Mushait, Khamis Mushait, Saudi Arabia

Countries

Saudi Arabia

References

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.

Reference Type: DERIVED

PMID: 31609464 (View on PubMed)

Other Identifiers

AFHSR-13-7-2013

Identifier Type: -

Identifier Source: org_study_id