Enhanced vs. Routine Clear Liquid Intake in Labor

Ketosis Clinical Trial

Official title:

Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524002
• Other study ID #: 22375
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: June 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• Nulliparity (first baby)

• Admission with the intent to deliver vaginally

• Gestational age >36 weeks

• Age = 18

Exclusion criteria:

• Planned cesarean delivery

• Renal Disease

• Preeclampsia

• Diabetes (Pre-gestational or Gestational)

• Allergy to any component of sports drink

• NPO diet by physician

Related Conditions & MeSH terms

• Abnormal Labor
• Dystocia
• Failed Induction of Labor
• Ketosis

Intervention

Dietary Supplement:
• Accel Gel
Accel Gel by PacificHealth Labs in Matawan, NJ.
• Usual clear diet
Usual clear liquids

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from admission to delivery	Up to 3 days from time of admission	Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary	Duration of second stage of labor	Time of complete cervical dilation to delivery of infant	Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary	delivery in <24 hours		Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary	cesarean delivery		Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary	rate of composite adverse GI outcome (vomiting or diarrhea)	Any vomiting or diarrhea	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	patient satisfaction with diet		Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary	Urine Ketones		Participants will be followed during labor until full dilation, an expected range of 1-48 hours