A Trial of Intravenous Fluids During Labor (RARHY)

Penn State Health

Status: Completed

Conditions: Ketosis

Treatments: Other: D5 Lactated Ringer's Solution (D5LR); Other: Lactated Ringer's Solution (LR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01110005

32118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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318 participants in 2 patient groups

D5 Lactated Ringer's solution (D5LR)

Active Comparator group

Description:

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

Treatment:

Other: D5 Lactated Ringer's Solution (D5LR)

Lactated Ringer's solution (LR)

Active Comparator group

Description:

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

Treatment:

Other: Lactated Ringer's Solution (LR)