Enhanced vs. Routine Clear Liquid Intake in Labor

NCT02524002 | Completed

• 1 other identifier: 22375
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Labor; Failed Induction of Labor; Ketosis

Keywords

Abnormal Labor; Prolonged Induction; Ketosis; Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of second stage of labor

  Participants will be followed during labor until delivery, an expected range of 1-48 hours

• delivery in <24 hours

  Participants will be followed during labor until delivery, an expected range of 1-48 hours

• cesarean delivery

  Participants 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

• patient satisfaction with diet

  Participants will be followed during labor until delivery, an expected range of 1-48 hours

Study Arms (2)

Usual Clear Diet

PLACEBO COMPARATOR

This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.

Dietary Supplement: Usual clear diet

Accel Gel

EXPERIMENTAL

This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used). http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html

Dietary Supplement: Accel Gel

Interventions

Accel Gel DIETARY_SUPPLEMENT

Accel Gel by PacificHealth Labs in Matawan, NJ.

Accel Gel

Usual clear diet DIETARY_SUPPLEMENT

Usual clear liquids

Usual Clear Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparity (first baby)
• Admission with the intent to deliver vaginally
• Gestational age \>36 weeks
• Age ≥ 18

You may not qualify if:

• Planned cesarean delivery
• Renal Disease
• Preeclampsia
• Diabetes (Pre-gestational or Gestational)
• Allergy to any component of sports drink
• NPO diet by physician

Sponsors & Collaborators

• Temple University: lead
• Stanford University: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Dystocia; Ketosis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Laura Goetzl, M.D.

  Temple University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 14, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)