The Use of D5LR Versus LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

Study Overview
=================
Brief Summary
-----------------
Currently, the optimum IV fluid for induction of labor is unknown. The goal of this study is to determine the optimum fluid for induction of labor, D5LR versus LR. The investigators hypothesize that patients assigned to the D5LR group will have a shorter induction of labor when compared to patient's in the LR group.

Detailed Description
-----------------
Induction of labor is increasingly common in the United States, as the overall rate has increased from 9.5% in 1990 to 22.1% in 2006 with the goal to stimulate contractions prior to the onset of spontaneous labor. Cesarean delivery rates are also at an all-time high in the U.S., with more than 32% of patients being delivered by Cesarean in 2009. One of the most common indications for Cesarean section is a prolonged labor course. Patient's with a prolonged labor course are also at risk for infections, including chorioamnionitis and endometritis, as well as an increased risk of postpartum hemorrhage. There is a lack of information on ways to help shorten labor to potentially minimize these risks. The uterus is comprised of skeletal muscle, and labor has been likened to prolonged rigorous exercise. While oral hydration has been endorsed by ACOG for low-risk women in spontaneous labor, solid foods should be avoided. In turn, women with a prolonged induction or labor may benefit from glucose supplementation via IV fluids. The DEXTRONS study, J. Pare et al., looked at supplementation of D5LR versus normal saline in nulliparous patients who presented for a favorable induction of labor. This study showed a significant reduction in active labor time in the D5LR group versus the normal saline group. Currently, at Genesys Regional Medical Center, lactated ringers is the preferred IV fluid for patients presenting for induction of labor. This study will randomly assign patients to D5LR versus lactated ringers and examine the length of time from induction to delivery to determine if glucose supplementation has an effect on reducing length of induction in both nulliparous and multiparous patients for either a favorable induction of labor or an induction for post-dates. Secondary outcomes will include Apgar scores, need for special care nursery/NICU admissions, and mode of delivery. The study will begin in January 2019 and continue through July 2019. Patients who presented to labor and delivery and consent to be included in the study will be randomized to each group.

Official Title
-----------------
A Randomized Controlled Trial Comparing D5LR to LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

Conditions
-----------------
Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
-----------------
* Other: Lactated ringers
* Other: 5% dextrose lactated ringers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women, age 18 - 45, that were admitted for induction of labor without any co-morbid conditions and their respective newborns with Induction of labor Singleton pregnancies Vertex presentation Pregnancies at 39 0/7 weeks gestation - 41 6/7 weeks gestation All races/ethnicities Exclusion Criteria: Multifetal gestations Noncephalic presentation Preexisting medical conditions: Maternal cardiac disease Lung diseases Chronic hypertension Pregestational or gestational diabetes gHTN or Pre-Eclampsia medical indication for induction of labor (olighydramnios, IUGR)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primiparous Patient, Unfavorable Bishop Score<br>Patient to receive D5LR or LR at 125 cc/hr | Other: Lactated ringers<br>* IV fluid<br>Other: 5% dextrose lactated ringers<br>* IV fluid<br>|
| Active Comparator: Primiparous Patient, Favorable Bishop Score<br>Patient to receive D5LR or LR at 125 cc/hr | Other: Lactated ringers<br>* IV fluid<br>Other: 5% dextrose lactated ringers<br>* IV fluid<br>|
| Active Comparator: Multiparous patient, Unfavorable Bishop Score<br>Patient to receive D5LR or LR at 125 cc/hr | Other: Lactated ringers<br>* IV fluid<br>Other: 5% dextrose lactated ringers<br>* IV fluid<br>|
| Active Comparator: Multiparous patient, Favorable Bishop Score<br>Patient to receive D5LR or LR at 125 cc/hr | Other: Lactated ringers<br>* IV fluid<br>Other: 5% dextrose lactated ringers<br>* IV fluid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of induction | Time from start of labor induction to delivery of infant | 492 min +/- 35 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Active Labor | time from 6 cm dilation until delivery of infant | 4 hours +/- 3 hours | 
| Apgar Scores | validated measure of infant health | 492 min +/- 35 min | 
| Mode of Delivery | Cesarean section vs SVD vs OVD | 492 min +/- 35 min | 
| Neonatal ICU admissions | ICU or special care nursery admissions | 24 hours after delivery | 
| Need for respiratory support | Neonatal need for respiratory support | 24 hours after delivery | 
| Transfer to tertiary care center | neonatal need for transfer to higher level NICU | 24 hours after delivery |