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Completed

NCT Number: NCT02524002

Enhanced vs. Routine Clear Liquid Intake in Labor

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.

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Key information

Conditions

Abnormal Labor Acid-Base Imbalance Acidosis Dystocia Failed Induction of Labor Female Urogenital Diseases and Pregnancy Complications Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accel Gel

Dietary Supplement

Accel Gel by PacificHealth Labs in Matawan, NJ.

Usual clear diet

Dietary Supplement

Usual clear liquids

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. delivery in <24 hours

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

  3. cesarean delivery

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

  4. 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

  5. patient satisfaction with diet

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

  6. Urine Ketones

    Time frame: Participants will be followed during labor until full dilation, an expected range of 1-48 hours

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Stanford University

Registry information

Official study title

Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2015
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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