Overview

This trial is active, not recruiting.

Condition ketosis
Treatments d5 lactated ringers solution (d5lr), lactated ringers solution (lr)
Sponsor Milton S. Hershey Medical Center
Collaborator Lehigh Valley Hospital
Start date April 2010
End date April 2013
Trial size 1524 participants
Trial identifier NCT01110005, 32118

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Analysis with and without adjusting (post hoc) for ketonuria for primary and secondary outcomes of interest with and without controlling for confounders as indicated.
d5 lactated ringers solution (d5lr) IV fluid containing glucose
IV fluid 125 ml/hr infusion rate
(Active Comparator)
Analyses with and without adjusting (post-hoc) for ketonuria for primary and secondary outcomes of interest, with and without controlling for confounders as indicated.
lactated ringers solution (lr) Non-Glucose containing solution
IV fluid 125 ml/hr infusion rate

Primary Outcomes

Measure
Number of C-Section versus Vaginal Birth
time frame: 28 months

Secondary Outcomes

Measure
Incidence of Ketosis
time frame: Outcome measure will be assessed approx 28 months. 15 women per center per month over two year enrollment and 3 months to clean data
Influence of Ketonuria
time frame: 28 months
Incidence of Prolonged Labor
time frame: 28 months
Need for Oxytocin Augmentation
time frame: 28 months
Incidence of Operative Vaginal Delivery
time frame: 28 months
Incidence of Chorioamnionitis
time frame: 28 months
Indications for Cesarean Birth
time frame: 28 months
Maternal Nausea/Vomiting in Labor
time frame: 28 months
Reduced Umbilical Artery pH/fetal Acidemia and Increased Umbilical Arter C02/fetal hypercarbia
time frame: 28 months
Neonatal Hypoglycemia
time frame: 28 months
Neonatal Intensive Care Unit Admission
time frame: 28 months
Difficulties with Initiating Breast Feeding
time frame: 28 months

Eligibility Criteria

Female participants of any age.

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).

Additional Information

Official title A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
Principal investigator John Smulian, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.