Effect of Carbohydrate Ingestion During Active LaborNCT02642588
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
A study testing energy gel in people with Effect of Carbohydrate Ingestion During Active Labor, run by University Hospitals Cleveland Medical Center.
Trial summary
Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only. 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
- Effect of Carbohydrate Ingestion During Active Labor
- What is being tested?
- energy gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jan 2019
- 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
- Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients with BMI < 35 kg/m^2
- Gestational age >37 weeks
Who cannot join
- - Patients younger than 18 years,
- Patients unable or unwilling to provide informed consent,
- Patients who are illiterate,
- Patients who are non-English speaking or reading,
- Patients who are University Hospital employees,
- Patients undergoing induction of labor for maternal or fetal indications other than elective induction after 39 weeks or induction for post-term pregnancy
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- Multi-fetal gestations (>1 intrauterine pregnancy),
- Patients with a history of GI disorders such as hyperemesis gravidarum, inflammatory bowel disease or irritable bowel syndrome
- Patients with an increased risk of aspiration such as BMI >35 kg/m^2, severe GERD, gastroesophageal motility disorders,
- Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome) which may necessitate need for general anesthetic for Cesarean delivery
- Patients with history of peptic ulcer disease,
- Patients who have a contraindication to epidural placement and would require general anesthestetic in event of Cesarean delivery
- Patients with suspected or proven placenta accreta, increta or percreta,
- Patients with excessive nausea or vomiting during labor
- Patients with a history of food allergies or allergies to specific components found in the energy gel.
About this study
Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only.
- Being tested
- energy gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy gelDietary supplement
energy gel: gelatinous edible containing carbohydrates typically used during endurance races
| Study group | Role | What they receive |
|---|---|---|
| energy gel | Experimental | women will be given 22 g of carbohydrates every 45-60 minutes for up to 8 hours or until delivery during the active phase of labor Receives: Dietary Supplement: energy gel |
| control | No intervention | women will be given only clear liquids during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
evaluated by visual analog scale
Measured: every 2 hours until delivery
duration of labor
will measure time to delivery and duration of 2nd stage of labor
Measured: from start of active phase until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startAug 2016
- Primary completionFeb 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Carbohydrate Ingestion During Active LaborStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Melissa March, Alison Bauer, Gaetan Pettigrew, Daisy Hassani, Celina Cunanan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642588
- Sponsor's protocol ID
- UHCaseMC
- Status last verified
- May 2022
- First submitted
- 24 Dec 2015
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02642588
- Acronym / sponsor ID
- UHCaseMC
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Melissa March, Alison Bauer, Gaetan Pettigrew, Daisy Hassani, Celina Cunanan
- Study start
- Aug 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 30 Dec 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.
Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| energy gel | Experimental | Dietary Supplement: energy gelwomen will be given 22 g of carbohydrates every 45-60 minutes for up to 8 hours or until delivery during the active phase of labor |
| control | No intervention | –women will be given only clear liquids during labor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients with BMI < 35 kg/m^2
- Gestational age >37 weeks
Key exclusion criteria (15 listed)
- - Patients younger than 18 years,
- Patients unable or unwilling to provide informed consent,
- Patients who are illiterate,
- Patients who are non-English speaking or reading,
- Patients who are University Hospital employees,
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 |
|---|---|---|
| energy gelenergy gel: gelatinous edible containing carbohydrates typically used during endurance races | Dietary supplement | energy gel |
Primary outcome
Fatigue
Time frame: every 2 hours until delivery
evaluated by visual analog scale
duration of labor
Time frame: from start of active phase until delivery
will measure time to delivery and duration of 2nd stage of labor
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing energy gel in people with Effect of Carbohydrate Ingestion During Active Labor, run by University Hospitals Cleveland Medical Center.
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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 6 May 2022. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fatigue (time frame: every 2 hours until delivery). The study lists 2 primary outcomes in all. 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 6 May 2022.