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Enhanced vs. Routine Clear Liquid Intake in Labor

Not Applicable
Completed
Conditions
Ketosis
Abnormal Labor
Failed Induction of Labor
Registration Number
NCT02524002
Lead Sponsor
Temple University
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 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 & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
76
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Time from admission to deliveryParticipants will be followed during labor until delivery, an expected range of 1-48 hours

Up to 3 days from time of admission

Secondary Outcome Measures
NameTimeMethod
delivery in <24 hoursParticipants will be followed during labor until delivery, an expected range of 1-48 hours
Urine KetonesParticipants will be followed during labor until full dilation, an expected range of 1-48 hours
Duration of second stage of laborParticipants will be followed during labor until delivery, an expected range of 1-48 hours

Time of complete cervical dilation to delivery of infant

cesarean deliveryParticipants will be followed during labor until delivery, an expected range of 1-48 hours
rate of composite adverse GI outcome (vomiting or diarrhea)Participants will be followed for the duration of hospital stay, an expected average of 5 days

Any vomiting or diarrhea

patient satisfaction with dietParticipants will be followed during labor until delivery, an expected range of 1-48 hours

Trial Locations

Locations (1)

Temple University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States

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