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Completed

NCT Number: NCT01110005

A Trial of Intravenous Fluids During Labor

The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

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About this study

This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery.

The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.
  • These women will be in good health and candidates for vaginal delivery.

Exclusion criteria

  • Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.
  • Patients presenting for induction of labor or requiring induction upon admission.
  • Patients presenting for scheduled cesarean section.
  • Patients with any form of diabetes or glucose dysregulation condition.
  • Concurrent use of steroids.
  • Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).
  • Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).

Treatment and study plan

D5 Lactated Ringer's Solution (D5LR)

Other

D5LR IV fluid

Lactated Ringer's Solution (LR)

Other

LR IV fluid

Primary outcomes

  1. C-Section

    Time frame: From onset of labor to delivery

    Compare c-section rates between the D5LR and LR treatment groups

Secondary outcomes

  1. Oxytocin Augmentation

    Time frame: From onset of labor to delivery

    Compare augmentation rates between the D5LR and LR treatment groups

  2. Time to Delivery

    Time frame: From onset of labor to delivery

    Compare time to delivery between the D5LR and LR treatment groups

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Lehigh Valley Hospital
  • St. Luke's Hospital, Pennsylvania
  • The Reading Hospital and Medical Center

Registry information

Official study title

A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor

Acronym: RARHY

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2010
Registry last updated
Jan 19, 2024

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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