LaborPhase 2NCT00569439
A Study on the Effects of Dextrose Solutions on the Course of Labor
A Phase 2 study testing D5NS, D10NS and NS in people with Labor, run by MemorialCare.
Trial summary
The purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor
- What is being tested?
- D5NS, D10NS and NS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Jun 2007
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Multiparous
- Pregestational or gestational diabetes mellitus
- Preeclampsia at admission
- Previous cesarean section
- Non-vertex presentation
- Multiple gestation
Show all 9Show fewer
- Chorioamnionitis at admission
- Intrauterine growth restriction (< 10th percentile)
- Patients admitted for induction
About this study
Official title: A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas
The purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. The researchers' hypothesis is that the addition of a carbohydrate substrate will shorten the length of labor and facilitate a vaginal delivery.
Read the detailed description
Factors that affect the course of labor have been studied extensively. Surprisingly, there is little data on the effect that different types and rates of intravenous (IV) fluids have during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized, controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased rate of cesarean section.
We propose that inadequate carbohydrate replacement in labor may also contribute to prolongation of labor and increased need for operative delivery. Glucose is the main energy supply for the pregnant uterus. Physiological requirements for glucose during labor are approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise tolerance and muscle efficiency, which are important factors in the progress of labor. Dysfunctional labor or dystocia, which is the leading indication for primary cesarean delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle effort in the second stage of labor. It contributes to increased risk for chorioamnionitis, which is a leading cause of maternal and fetal morbidity and mortality. Supplying carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and, therefore, diminish risk for chorioamnionitis and need for cesarean delivery.
- Conditions
- Labor
- Being tested
- D5NS, D10NS, NS
- Keywords
- Labor, Carbohydrate, Dystocia
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D5NSDrug
5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
D10NSDrug
10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
NSDrug
Normal Saline solution at 125 cc/hr
| Study group | Role | What they receive |
|---|---|---|
| D5 | Experimental | 5% Dextrose Solution in Normal Saline Receives: Drug: D5NS |
| D10 | Experimental | Not described Receives: Drug: D10NS |
| NS | Placebo comparator | Not described Receives: Drug: NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes)
Measured: Prospective
Secondary outcomes (4)
Carbohydrate solutions can decrease the incidence of prolonged labor (> 12 hours
Measured: Prospective
Carbohydrate solutions can decrease the incidence of chorioamnionitis during labor
Measured: Prospective
Carbohydrate solutions can decrease the need for oxytocin (a contraction stimulant) augmentation of labor
Measured: Prospective
Carbohydrate solutions can decrease the frequency of cesarean sections for prolonged labor
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startNov 2000
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Chan, M.D., Principal investigator, Memorial CareSherri Jenkins, M.D., Principal investigator, University of Alabama at BirminghamThomas J. Garite, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569439
- Sponsor's protocol ID
- 035-00
- Status last verified
- Jun 2006
- First submitted
- 6 Dec 2007
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas
- ClinicalTrials.gov ID
- NCT00569439
- Acronym / sponsor ID
- 035-00
- Conditions
- Labor
- Keywords
- Labor, Carbohydrate, Dystocia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- MemorialCareUniversity, hospital or other
- Study start
- Nov 2000
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Dec 2007 (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 purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. The researchers' hypothesis is that the addition of a carbohydrate substrate will shorten the length of labor and facilitate a vaginal delivery.
Detailed description
Factors that affect the course of labor have been studied extensively. Surprisingly, there is little data on the effect that different types and rates of intravenous (IV) fluids have during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized, controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased rate of cesarean section.
We propose that inadequate carbohydrate replacement in labor may also contribute to prolongation of labor and increased need for operative delivery. Glucose is the main energy supply for the pregnant uterus. Physiological requirements for glucose during labor are approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise tolerance and muscle efficiency, which are important factors in the progress of labor. Dysfunctional labor or dystocia, which is the leading indication for primary cesarean delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle effort in the second stage of labor. It contributes to increased risk for chorioamnionitis, which is a leading cause of maternal and fetal morbidity and mortality. Supplying carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and, therefore, diminish risk for chorioamnionitis and need for cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D5 | Experimental | Drug: D5NS5% Dextrose Solution in Normal Saline |
| D10 | Experimental | Drug: D10NS |
| NS | Placebo comparator | Drug: NS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Multiparous
- Pregestational or gestational diabetes mellitus
- Preeclampsia at admission
- Previous cesarean section
- Non-vertex presentation
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 |
|---|---|---|
| D5NS5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr | Drug | D5 |
| D10NS10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr | Drug | D10 |
| NSNormal Saline solution at 125 cc/hr | Drug | NS |
Primary outcome
Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes)
Time frame: Prospective
4 secondary outcomes
Carbohydrate solutions can decrease the incidence of prolonged labor (> 12 hours
Time frame: Prospective
Carbohydrate solutions can decrease the incidence of chorioamnionitis during labor
Time frame: Prospective
Carbohydrate solutions can decrease the need for oxytocin (a contraction stimulant) augmentation of labor
Time frame: Prospective
Carbohydrate solutions can decrease the frequency of cesarean sections for prolonged labor
Time frame: Prospective
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 7 Dec 2007.
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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.
Kenneth Chan, M.D. principal investigator
Memorial Care
Sherri Jenkins, M.D. principal investigator
University of Alabama at Birmingham
Thomas J. Garite, M.D. principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D5NS, D10NS and NS in people with Labor, run by MemorialCare.
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 0 inclusion and 9 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 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes) (time frame: Prospective). 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 7 Dec 2007.