CClinicalTrials.gg
CompletedNCT02655783DEXTRONSUpdated Oct 31, 2016

Use of Normal Saline With or Without Dextrose During Induction of Labor in Nulliparous

An interventional study of 5% dextrose and normal saline in Delivery Uterine, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-31.

Sponsored by Université de Sherbrooke · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The objective of this study is to compare the effects of use of normal saline (250 cc / h), with or without dextrose supplement, on the evolution of labor in nulliparous.

Read the detailed description

There is some controversy regarding intravenous hydration of patients during labor. While the use of a fast flow of hydration appears to be recognized beneficial, the addition of glucose is less well accepted. However studies on exercise physiology clearly demonstrates improved performance of skeletal muscle by increased hydration and carbohydrate replacement during prolonged exercise. This situation is similar to the condition of the uterus in labor especially since it is now established that glucose represents its principal source of energy.

However, the effect of an additional carbohydrate intake on the evolution of labor has not been extensively studied until now, and there are several schools of thought on this subject. While some studies show that such glucose addition could reduce the total duration of labor as well as its second stage, others claim that this glucose supplement offers no benefit and may even be harmful to the fetus.

It therefore seems imperative to conduct a study to compare the use of hydration with normal saline with or without dextrose during labor, as recommended in current flow (250 cc / h). To our knowledge, this has never been done.

02

Conditions studied

  • Delivery Uterine

Keywords

  • induction of labor
03

In context

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • nulliparous woman
  • monofetal pregnancy
  • delivery at term
  • elective induction
  • favorable cervix (Bishop score of at least 6)
  • cephalic presentation

Exclusion criteria

Exclusion Criteria:

  • diabetes
  • preeclampsia
  • maternal heart disease
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    control

    normal saline, 250 ml/h, until expulsion of placental

    Other: normal saline

  • Experimental
    intervention

    normal saline + 5% dextrose, 250 ml/h, until expulsion of placental

    Other: 5% dextrose · Other: normal saline

Interventions

  • Other5% dextrose

    women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose

  • Othernormal saline

    women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution

06

What researchers measure

Primary outcomes

  1. 2nd stage of labor

    Time frame: during delivery of a first baby, for an average of 5 hours

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
08

References and documents

Individual participant data

Plan to share: Yes — Oral presentation at the Society of Maternal and Fetal Medicine annual meeting (January 2017, Las Vegas) Manuscript in preparation

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02655783
Lead sponsor
Université de Sherbrooke
Responsible party
Sponsor
First posted
Jan 14, 2016
Start date
Jan 2013
Primary completion
Mar 2016
Completion
Sep 2016
Last update
Oct 31, 2016

Study contacts

Yves-André Bureau, MD
principal investigator · Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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