Length of LaborNCT01904617
Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
A study testing Dextrose and Normal Saline in people with Length of Labor and Second Stage of Labor, run by MemorialCare Health System at 1 site in United States.
Trial summary
This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Length of Labor, Second Stage of Labor, Intravenous Hydration of Labor
- What is being tested?
- Dextrose and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Primiparous
- Singleton gestation
- Vertex presentation
- Spontaneous active labor with or without pitocin augmentation
- Gestational age > 36 weeks
- Cervical dilation 3 to 5 cm with or without ruptured membranes
Who cannot join
- • Multiparous
- Pregestational or gestational diabetes mellitus
- Preeclampsia at admission
- Previous cesarean section
- Non-vertex presentation
- Multiple gestation
Show all 10Show fewer
- Chorioamnionitis at admission
- Intrauterine growth restriction (< 10th percentile)
- Patients admitted for induction
- BMI > 50
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Beach Memorial Medical Center
Long Beach, California, 90806
About this study
Official title: A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline
Read the detailed description
Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.
Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.
Subjects will be blindly randomized to receive one of three different types of IV fluids:
- 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
- Normal saline (a solution containing sodium and chloride) at 250 mL/hr
- 2.5% dextrose Normal saline at 125 mL/hr
- Management of labor will be at the discretion of the attending physician(s).
- Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
- Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.
- Being tested
- Dextrose, Normal Saline
- Keywords
- Length of labor, second stage of labor, intravenous hydration of labor, intravenous glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroseOther
Normal SalineOther
Also called Intravenous fluids, normal saline
| Study group | Role | What they receive |
|---|---|---|
| D5NS at 125 mL/hr | Experimental | 5% dextrose in normal saline at 125 mL/hr Receives: Other: Dextrose; Other: Normal Saline |
| D2.5NS at 250mL/hr | Experimental | 2.5% dextrose in normal saline at 250 mL/hr Receives: Other: Dextrose; Other: Normal Saline |
| NS at 250mL/hr | Experimental | Normal saline at 250mL/hr Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of labor
Measured: Time from fluid initiation to delivery
Secondary outcomes (1)
Time of second stage of labor
Measured: Time from initiation of pushing to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Length of LaborStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vineet Shrivastava, MD, Principal investigator, Long Beach Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904617
- Sponsor's protocol ID
- 025-11
- Status last verified
- Jan 2015
- First submitted
- 19 Apr 2013
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
- ClinicalTrials.gov ID
- NCT01904617
- Acronym / sponsor ID
- 025-11
- Keywords
- Length of labor, second stage of labor, intravenous hydration of labor, intravenous glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Jul 2013 (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.
This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline
Detailed description
Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.
Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.
Subjects will be blindly randomized to receive one of three different types of IV fluids:
- 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
- Normal saline (a solution containing sodium and chloride) at 250 mL/hr
- 2.5% dextrose Normal saline at 125 mL/hr
- Management of labor will be at the discretion of the attending physician(s).
- Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
- Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D5NS at 125 mL/hr | Experimental | Other: Dextrose, Other: Normal Saline5% dextrose in normal saline at 125 mL/hr |
| D2.5NS at 250mL/hr | Experimental | Other: Dextrose, Other: Normal Saline2.5% dextrose in normal saline at 250 mL/hr |
| NS at 250mL/hr | Experimental | Other: Normal SalineNormal saline at 250mL/hr |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Primiparous
Key exclusion criteria (10 listed)
- • Multiparous
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 |
|---|---|---|
| Dextrose | Other | D2.5NS at 250mL/hr, D5NS at 125 mL/hr |
| Normal SalineAlso: Intravenous fluids, normal saline | Other | D2.5NS at 250mL/hr, D5NS at 125 mL/hr, NS at 250mL/hr |
Primary outcome
Length of labor
Time frame: Time from fluid initiation to delivery
1 secondary outcome
Time of second stage of labor
Time frame: Time from initiation of pushing to delivery
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 8 Jan 2015.
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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.
Vineet Shrivastava, MD principal investigator
Long Beach Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose and Normal Saline in people with Length of Labor and Second Stage of Labor, run by MemorialCare Health System at 1 site in United States.
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 10 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 8 Jan 2015. 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 United States. 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?
Length of labor (time frame: Time from fluid initiation to delivery). 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 8 Jan 2015.