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Induction of Labor Affected Fetus / NewbornNCT03822052

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 study testing Lactated ringers and 5% dextrose lactated ringers in people with Induction of Labor Affected Fetus / Newborn, run by Ascension Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Lactated ringers and 5% dextrose lactated ringers
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
15 Mar 2019to 19 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Multifetal gestations
  • Noncephalic presentation
  • Preexisting medical conditions:
  • Maternal cardiac disease
  • Lung diseases
  • Chronic hypertension
Show all 9Show fewer
  • Pregestational or gestational diabetes
  • gHTN or Pre-Eclampsia
  • medical indication for induction of labor (olighydramnios, IUGR)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ascension Genesys Hospital

    Grand Blanc, Michigan, 48439

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Lactated ringers, 5% dextrose lactated ringers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactated ringersOther

    IV fluid

  • 5% dextrose lactated ringersOther

    IV fluid

Study groups in NCT03822052
Study groupRoleWhat they receive
Primiparous Patient, Unfavorable Bishop ScoreActive comparatorPatient to receive D5LR or LR at 125 cc/hr
Receives: Other: Lactated ringers; Other: 5% dextrose lactated ringers
Primiparous Patient, Favorable Bishop ScoreActive comparatorPatient to receive D5LR or LR at 125 cc/hr
Receives: Other: Lactated ringers; Other: 5% dextrose lactated ringers
Multiparous patient, Unfavorable Bishop ScoreActive comparatorPatient to receive D5LR or LR at 125 cc/hr
Receives: Other: Lactated ringers; Other: 5% dextrose lactated ringers
Multiparous patient, Favorable Bishop ScoreActive comparatorPatient to receive D5LR or LR at 125 cc/hr
Receives: Other: Lactated ringers; Other: 5% dextrose lactated ringers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of induction

    Time from start of labor induction to delivery of infant

    Measured: 492 min +/- 35 min

Secondary outcomes (6)

  1. Time of Active Labor

    time from 6 cm dilation until delivery of infant

    Measured: 4 hours +/- 3 hours

  2. Apgar Scores

    validated measure of infant health

    Measured: 492 min +/- 35 min

  3. Mode of Delivery

    Cesarean section vs SVD vs OVD

    Measured: 492 min +/- 35 min

  4. Neonatal ICU admissions

    ICU or special care nursery admissions

    Measured: 24 hours after delivery

  5. Need for respiratory support

    Neonatal need for respiratory support

    Measured: 24 hours after delivery

  6. Transfer to tertiary care center

    neonatal need for transfer to higher level NICU

    Measured: 24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start15 Mar 2019
  3. Primary completion15 Nov 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822052
Sponsor's protocol ID
ME 19 004
Status last verified
Dec 2019
First submitted
18 Jan 2019
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fong A, Serra AE, Caballero D, Garite TJ, Shrivastava VK. A randomized, double-blinded, controlled trial of the effects of fluid rate and/or presence of dextrose in intravenous fluids on the labor course of nulliparas. Am J Obstet Gynecol. 2017 Aug;217(2):208.e1-208.e7. doi: 10.1016/j.ajog.2017.03.010. Epub 2017 Mar 18.

    PubMed 28322776

  • Sharma C, Kalra J, Bagga R, Kumar P. A randomized controlled trial comparing parenteral normal saline with and without 5% dextrose on the course of labor in nulliparous women. Arch Gynecol Obstet. 2012 Dec;286(6):1425-30. doi: 10.1007/s00404-012-2485-1. Epub 2012 Aug 4.

    PubMed 22865033

  • ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

    PubMed 19623003

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

    PubMed 28937571

  • ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.

    PubMed 30575678

  • ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.

    PubMed 30575638

  • Philipson EH, Kalhan SC, Riha MM, Pimentel R. Effects of maternal glucose infusion on fetal acid-base status in human pregnancy. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):866-73. doi: 10.1016/s0002-9378(87)80075-3.

    PubMed 3314516

  • Pare J, Pasquier JC, Lewin A, Fraser W, Bureau YA. Reduction of total labor length through the addition of parenteral dextrose solution in induction of labor in nulliparous: results of DEXTRONS prospective randomized controlled trial. Am J Obstet Gynecol. 2017 May;216(5):508.e1-508.e7. doi: 10.1016/j.ajog.2017.01.010. Epub 2017 Jan 30.

    PubMed 28153654

Questions about this trial

What is this clinical trial studying?

A study testing Lactated ringers and 5% dextrose lactated ringers in people with Induction of Labor Affected Fetus / Newborn, run by Ascension Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of induction (time frame: 492 min +/- 35 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822052, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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