Clinical Trials Logo

Clinical Trial Summary

The purpose of our study is to determine if the incidence of emesis can be lowered with the addition of a high protein drink during labor. Emesis and nausea are the leading causes of parturient dissatisfaction, results in a delay of returning to normal, daily living and can hugely impact the mother's postpartum experience. To date, no studies have been done on the relationship of protein intake during labor and incidence of emesis. To the best of our knowledge, the use of a high protein drink during labor has not been evaluated in the literature.


Clinical Trial Description

The investigators plan to enroll women (n=150) who requested epidural anesthesia for labor. After placement of their labor epidural catheter, parturients will be randomized by a computer generated number table into one of two groups. Group P - high protein drink with 30 grams of protein and ice chips PRN, or Group C - control group consisting of ice chips PRN. The protein drink that will be used is Premier Nutrition Protein Shake, which contains 30 grams of protein in 11 ounces. Measured variables will include; nausea and emesis at epidural placement, at hourly intervals until delivery, and 1 hour post delivery. Nausea will be evaluated using a visual analog scale (VAS); 0 = no nausea and 10 = worst nausea ever. Episodes of emesis will be recorded as (yes/no). The parturient will be seen the day following delivery and evaluated for overall patient satisfaction. Parturients will rate their satisfaction level using a scale from 0-100 with 0=not satisfied and 100=very satisfied. The investigators believe that the incidence of emesis will be decreased in parturients who receive high protein intake during labor, and overall patient satisfaction will be increased. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01414478
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date August 2010
Completion date August 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01913990 - Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. Phase 4
Terminated NCT00869973 - Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients Phase 3
Terminated NCT00869310 - Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis Phase 3
Completed NCT04719286 - MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy N/A
Completed NCT01046240 - Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy Phase 1/Phase 2
Recruiting NCT03478605 - Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis Phase 2
Recruiting NCT04564144 - Evaluation of Meclizine Orodispersible Tablet Pharmacokinetic in Human Volunteers Phase 1/Phase 2
Terminated NCT01148264 - Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis Phase 2
Completed NCT01509417 - Different Feeding Methods After Pyloromyotomy N/A
Completed NCT00152867 - Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy Phase 3
Completed NCT04182750 - Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study N/A
Completed NCT02980289 - DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
Completed NCT02602080 - Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Completed NCT04585841 - The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy Phase 1
Not yet recruiting NCT02407600 - Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy Phase 2