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

October 27, 2016 updated by: Université de Sherbrooke

Utilisation parentérale de Normal Salin Avec ou Sans Dextrose Durant l'Induction du Travail Chez Les Nullipares

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • preeclampsia
  • maternal heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
normal saline, 250 ml/h, until expulsion of placental
Other: normal saline
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution
Experimental: intervention
normal saline + 5% dextrose, 250 ml/h, until expulsion of placental
Other: normal saline
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution
Other: 5% dextrose
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2nd stage of labor
Time Frame: during delivery of a first baby, for an average of 5 hours
during delivery of a first baby, for an average of 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Yves-André Bureau, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Oral presentation at the Society of Maternal and Fetal Medicine annual meeting (January 2017, Las Vegas) Manuscript in preparation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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