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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03822052
Enrollment
39
Registered
2019-01-30
Start date
2019-03-15
Completion date
2019-12-19
Last updated
2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

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.

Interventions

IV fluid

OTHER5% dextrose lactated ringers

IV fluid

Sponsors

Ascension Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Time of induction492 min +/- 35 minTime from start of labor induction to delivery of infant

Secondary

MeasureTime frameDescription
Apgar Scores492 min +/- 35 minvalidated measure of infant health
Mode of Delivery492 min +/- 35 minCesarean section vs SVD vs OVD
Time of Active Labor4 hours +/- 3 hourstime from 6 cm dilation until delivery of infant
Need for respiratory support24 hours after deliveryNeonatal need for respiratory support
Transfer to tertiary care center24 hours after deliveryneonatal need for transfer to higher level NICU
Neonatal ICU admissions24 hours after deliveryICU or special care nursery admissions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026