Delivery UterineDEXTRONSNCT02655783
Use of Normal Saline With or Without Dextrose During Induction of Labor in Nulliparous
A study testing 5% dextrose and normal saline in people with Delivery Uterine, run by Université de Sherbrooke at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery Uterine
- What is being tested?
- 5% dextrose and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Sep 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nulliparous woman
- monofetal pregnancy
- delivery at term
- elective induction
- favorable cervix (Bishop score of at least 6)
- cephalic presentation
Who cannot join
- diabetes
- preeclampsia
- maternal heart disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 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.
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.
- Conditions
- Delivery Uterine
- Being tested
- 5% dextrose, normal saline
- Keywords
- induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% dextroseOther
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose
normal salineOther
women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | normal saline, 250 ml/h, until expulsion of placental Receives: Other: normal saline |
| intervention | Experimental | normal saline + 5% dextrose, 250 ml/h, until expulsion of placental Receives: Other: 5% dextrose; Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
2nd stage of labor
Measured: during delivery of a first baby, for an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery UterineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-André Bureau, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655783
- Sponsor's protocol ID
- 12-143
- Acronym
- DEXTRONS
- Status last verified
- Oct 2016
- First submitted
- 4 Mar 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Oral presentation at the Society of Maternal and Fetal Medicine annual meeting (January 2017, Las Vegas) Manuscript in preparation
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation parentérale de Normal Salin Avec ou Sans Dextrose Durant l'Induction du Travail Chez Les Nullipares
- ClinicalTrials.gov ID
- NCT02655783
- Acronym / sponsor ID
- DEXTRONS / 12-143
- Conditions
- Delivery Uterine
- Keywords
- induction of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: normal salinenormal saline, 250 ml/h, until expulsion of placental |
| intervention | Experimental | Other: 5% dextrose, Other: normal salinenormal saline + 5% dextrose, 250 ml/h, until expulsion of placental |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- nulliparous woman
- monofetal pregnancy
- delivery at term
- elective induction
- favorable cervix (Bishop score of at least 6)
Key exclusion criteria (3 listed)
- diabetes
- preeclampsia
- maternal heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% dextrosewomen with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose | Other | intervention |
| normal salinewomen with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution | Other | control, intervention |
Primary outcome
2nd stage of labor
Time frame: during delivery of a first baby, for an average of 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: Yes. Oral presentation at the Society of Maternal and Fetal Medicine annual meeting (January 2017, Las Vegas) Manuscript in preparation
Related trials for Delivery Uterine
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Not yet recruiting
Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves-André Bureau, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% dextrose and normal saline in people with Delivery Uterine, run by Université de Sherbrooke at 1 site in Canada.
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 3 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 31 Oct 2016. 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 Canada. 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?
2nd stage of labor (time frame: during delivery of a first baby, for an average of 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2016.