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

NCT ID: NCT02655783

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delivery Uterine

Keywords

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induction of labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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control

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

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type OTHER

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

intervention

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

Group Type EXPERIMENTAL

5% dextrose

Intervention Type OTHER

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

normal saline

Intervention Type OTHER

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

Interventions

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5% dextrose

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

Intervention Type OTHER

normal saline

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves-André Bureau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-143

Identifier Type: -

Identifier Source: org_study_id