A Trial of Intravenous Fluids During Labor

Ketosis Clinical Trial

— RARHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110005
• Other study ID #: 32118
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: January 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Ketosis

Intervention

Other:
• D5 Lactated Ringer's Solution (D5LR)
D5LR IV fluid
• Lactated Ringer's Solution (LR)
LR IV fluid

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	St. Luke Hospital	Bethlehem	Pennsylvania
United States	The Penn State University	Hershey	Pennsylvania
United States	The Reading Hospital and Medical Center	Reading	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Lehigh Valley Hospital, St. Luke's Hospital, Pennsylvania, The Reading Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-Section	Compare c-section rates between the D5LR and LR treatment groups	From onset of labor to delivery
Secondary	Oxytocin Augmentation	Compare augmentation rates between the D5LR and LR treatment groups	From onset of labor to delivery
Secondary	Time to Delivery	Compare time to delivery between the D5LR and LR treatment groups	From onset of labor to delivery