A Trial of Intravenous Fluids During Labor

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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D5 Lactated Ringer's solution (D5LR)

IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.

Group Type ACTIVE_COMPARATOR

D5 Lactated Ringer's Solution (D5LR)

Intervention Type OTHER

D5LR IV fluid

Lactated Ringer's solution (LR)

Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.

Group Type ACTIVE_COMPARATOR

Lactated Ringer's Solution (LR)

Intervention Type OTHER

LR IV fluid

Interventions

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D5 Lactated Ringer's Solution (D5LR)

D5LR IV fluid

Intervention Type OTHER

Lactated Ringer's Solution (LR)

LR IV fluid

Intervention Type OTHER

Eligibility Criteria

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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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes