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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02524002
Other study ID # 22375
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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