A Trial of Intravenous Fluids During Labor

Not Applicable

Completed

• Conditions: Ketosis
• Interventions: Other: D5 Lactated Ringer's Solution (D5LR); Other: Lactated Ringer's Solution (LR)

• Registration Number: NCT01110005
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-01
• Results First Submitted: 2017-01-24
• Results First Submitted QC: 2017-01-24
• Results First Posted: 2017-03-14
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 318

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D5 Lactated Ringer's solution (D5LR)	D5 Lactated Ringer's Solution (D5LR)	IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
Lactated Ringer's solution (LR)	Lactated Ringer's Solution (LR)	Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.

Primary Outcome Measures

Name	Time	Method
C-Section	From onset of labor to delivery	Compare c-section rates between the D5LR and LR treatment groups

Secondary Outcome Measures

Name	Time	Method
Time to Delivery	From onset of labor to delivery	Compare time to delivery between the D5LR and LR treatment groups
Oxytocin Augmentation	From onset of labor to delivery	Compare augmentation rates between the D5LR and LR treatment groups

Trial Locations

Locations (4)

The Reading Hospital and Medical Center; 🇺🇸 Reading, Pennsylvania, United States

St. Luke Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

The Penn State University; 🇺🇸 Hershey, Pennsylvania, United States