Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women
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|ClinicalTrials.gov Identifier: NCT01937234|
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : March 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prolonged First Stage of Labor||Drug: Metoclopramide Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
Active Comparator: Metoclopramide
Intravenous injection of 10mg metoclopramide
Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours.
Maximum of 3 doses.
Other Name: Primperan (Trademark)
Placebo Comparator: Placebo
Intravenous injection of 0.9% sodium chloride
Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours.
Maximum of 3 doses.
Other Name: Normal saline
- Cervical dilatation rate [ Time Frame: 6 hours ]
- Duration of the first stage of labor [ Time Frame: 6 hours ]
- Duration of the second stage of labor [ Time Frame: 2 hours ]
- Duration of the third stage of labor [ Time Frame: 1 hour ]
- Number of Participants with Adverse Events [ Time Frame: 24 hours ]
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)
- Apgar score [ Time Frame: 10 minutes ]
- Meconium stained liquor [ Time Frame: 6 hours ]
- Neonatal intensive care unit admission rate [ Time Frame: 24 hours ]
- Rate of vaginal delivery [ Time Frame: 12 hours ]
- Number of participants with genital tract injuries [ Time Frame: 2 hours ]
genital tract injuries:
- Perineal tears
- Vaginal tears
- Cervical tears
- Perineal hematomas
- Vaginal hematomas
- Uterine rupture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937234
|Labor and delivery ward of Armed Forces Hospital, Southern Region.|
|Khamis Mushait, Saudi Arabia, 101|
|Study Director:||Mohamed I Ellaithy, MD||Ain Shams University|