NCT02655783

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

March 4, 2015

Last Update Submit

October 27, 2016

Conditions

Delivery Uterine

Keywords

induction of labor

Outcome Measures

Primary Outcomes (1)

  • 2nd stage of labor

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

Study Arms (2)

control

ACTIVE COMPARATOR

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

Other: normal saline

intervention

EXPERIMENTAL

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

Other: 5% dextroseOther: normal saline

Interventions

5% dextroseOTHER

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

intervention
normal salineOTHER

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

controlintervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diabetes
  • preeclampsia
  • maternal heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Interventions

GlucoseSaline Solution

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yves-André Bureau, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

January 14, 2016

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

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

Locations

CA(1)