Clinical Trial: Enhanced vs. Routine Clear Liquid Intake in Labor

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

Brief Summary: The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

Detailed Summary: Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.
Sponsor: Temple University

Current Primary Outcome: Time from admission to delivery [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]

Up to 3 days from time of admission


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of second stage of labor [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
    Time of complete cervical dilation to delivery of infant
  • delivery in <24 hours [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  • cesarean delivery [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  • rate of composite adverse GI outcome (vomiting or diarrhea) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Any vomiting or diarrhea
  • patient satisfaction with diet [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  • Urine Ketones [ Time Frame: Participants will be followed during labor until full dilation, an expected range of 1-48 hours ]


Original Secondary Outcome: Same as current

Information By: Temple University

Dates:
Date Received: August 15, 2014
Date Started: August 2014
Date Completion: May 2018
Last Updated: November 4, 2016
Last Verified: November 2016