Abnormal LaborNCT02524002
Enhanced vs. Routine Clear Liquid Intake in Labor
A study testing Accel Gel and Usual clear diet in people with Abnormal Labor and Failed Induction of Labor, run by Temple University at 1 site in United States.
Trial summary
The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Labor, Failed Induction of Labor, Ketosis
- What is being tested?
- Accel Gel and Usual clear diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2017
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparity (first baby)
- Admission with the intent to deliver vaginally
- Gestational age >36 weeks
- Age ≥ 18
Who cannot join
- Planned cesarean delivery
- Renal Disease
- Preeclampsia
- Diabetes (Pre-gestational or Gestational)
- Allergy to any component of sports drink
- NPO diet by physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19102
About this study
Official title: Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance
The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.
Read the detailed description
Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.
- Conditions
- Abnormal Labor, Failed Induction of Labor, Ketosis
- Being tested
- Accel Gel, Usual clear diet
- Keywords
- Abnormal Labor, Prolonged Induction, Ketosis, Diet
- Medical subject headings
- Dystocia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accel GelDietary supplement
Accel Gel by PacificHealth Labs in Matawan, NJ.
Usual clear dietDietary supplement
Usual clear liquids
| Study group | Role | What they receive |
|---|---|---|
| Usual Clear Diet | Placebo comparator | This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice. Receives: Dietary Supplement: Usual clear diet |
| Accel Gel | Experimental | This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used).
http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html Receives: Dietary Supplement: Accel Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from admission to delivery
Up to 3 days from time of admission
Measured: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary outcomes (6)
Duration of second stage of labor
Time of complete cervical dilation to delivery of infant
Measured: Participants will be followed during labor until delivery, an expected range of 1-48 hours
delivery in <24 hours
Measured: Participants will be followed during labor until delivery, an expected range of 1-48 hours
cesarean delivery
Measured: Participants will be followed during labor until delivery, an expected range of 1-48 hours
rate of composite adverse GI outcome (vomiting or diarrhea)
Any vomiting or diarrhea
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
patient satisfaction with diet
Measured: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Urine Ketones
Measured: Participants will be followed during labor until full dilation, an expected range of 1-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Laura Goetzl, M.D., Principal investigator, Temple University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524002
- Sponsor's protocol ID
- 22375
- Status last verified
- Jun 2018
- First submitted
- 15 Aug 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance
- ClinicalTrials.gov ID
- NCT02524002
- Acronym / sponsor ID
- 22375
- Conditions
- Abnormal Labor, Failed Induction of Labor, Ketosis
- Keywords
- Abnormal Labor, Prolonged Induction, Ketosis, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Aug 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Aug 2015 (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 goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.
Detailed description
Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Clear Diet | Placebo comparator | Dietary Supplement: Usual clear dietThis intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice. |
| Accel Gel | Experimental | Dietary Supplement: Accel GelThis intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used). http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparity (first baby)
- Admission with the intent to deliver vaginally
- Gestational age >36 weeks
- Age ≥ 18
Key exclusion criteria (6 listed)
- Planned cesarean delivery
- Renal Disease
- Preeclampsia
- Diabetes (Pre-gestational or Gestational)
- Allergy to any component of sports drink
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 |
|---|---|---|
| Accel GelAccel Gel by PacificHealth Labs in Matawan, NJ. | Dietary supplement | Accel Gel |
| Usual clear dietUsual clear liquids | Dietary supplement | Usual Clear Diet |
Primary outcome
Time from admission to delivery
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Up to 3 days from time of admission
6 secondary outcomes
Duration of second stage of labor
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
delivery in <24 hours
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
cesarean delivery
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
rate of composite adverse GI outcome (vomiting or diarrhea)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
patient satisfaction with diet
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Urine Ketones
Time frame: Participants will be followed during labor until full dilation, an expected range of 1-48 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 12 Jun 2018.
- Individual participant dataSharing planned: Yes
Related trials for Abnormal Labor
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
Not yet recruiting
TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia
Shoulder Dystocia
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.
Laura Goetzl, M.D. principal investigator
Temple University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accel Gel and Usual clear diet in people with Abnormal Labor and Failed Induction of Labor, run by Temple University 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 4 inclusion and 6 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 12 Jun 2018. 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. 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.
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?
Time from admission to delivery (time frame: Participants will be followed during labor until delivery, an expected range of 1-48 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 12 Jun 2018.