Clinical trial NCT01110005: A Trial of Intravenous Fluids During Labor
Official title: A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Keywords: D5LR
glucose containing IV solution
LR
non glucose IV solution
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Lehigh Valley Hospital
name: The Reading Hospital and Medical Center
name: St. Luke's Hospital, Pennsylvania
First posted: 2010-04-23
Enrollment: 318
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: C-Section
timeFrame: From onset of labor to delivery
Secondary outcomes:
measure: Oxytocin Augmentation
timeFrame: From onset of labor to delivery
measure: Time to Delivery
timeFrame: From onset of labor to delivery
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: The Penn State University
state: Pennsylvania
city: Reading
country: United States
facility: The Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States
name: Richard S Legro, M.D.
role: STUDY_DIRECTOR
affiliation: Lehigh Valley Hospital, Allentown, Pennsylvania, United States
name: John Smulian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.