Labor, ObstetricNCT00367549
Nutrition as a Determinant of Labor Outcome
A study testing Energy-containing soft drink in people with Labor, Obstetric, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Obstetric
- What is being tested?
- Energy-containing soft drink
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Dec 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at gestational age > 36 weeks, parity 0
Who cannot join
- Gestational age < 36 weeks
- Signs of fetal pathology:
- Different or abnormal (pathological) CTG test performed just before start of the test
- Abnormal Doppler registrations (PI in the arteria umbilicae > 2SD for the gestational age)
- Established notch in the arteria uterinae or notch bilaterally or PI > 2SD > 24 weeks
- Diverging in the weight of the fetus > - 22% or diverging in the growth of the fetus - 10% or more, and established structural pathology in the fetus, oligohydramnion (amniotic fluid index < 6)
Show all 16Show fewer
- Maternal diseases and pregnancy complications
- diabetes in pregnancy
- high blood pressure
- cardiovascular diseases
- rheumatic disease
- epilepsia
- lung disease, etc.
- CTG test: cardiotocographic test (a measure of fetal activity)
- PI: pulsatory index (velocity pattern)
- SD: standard deviation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition as Determinant of Labor Outcome
This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.
Read the detailed description
Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.
- Conditions
- Labor, Obstetric
- Being tested
- Energy-containing soft drink
- Keywords
- Labor, instrumental delivery, nutrition, epidural anesthesia, oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy-containing soft drinkDietary supplement
Commercial energy/sports drink
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time
Measured: At time of birth
Secondary outcomes (4)
Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
Use of epidural anesthetics
Use of contraction-stimulating drugs
Instrumental delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, ObstetricStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Tore Henriksen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367549
- Sponsor's protocol ID
- REK-SØR: S-05308
- Status last verified
- May 2010
- First submitted
- 22 Aug 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition as Determinant of Labor Outcome
- ClinicalTrials.gov ID
- NCT00367549
- Acronym / sponsor ID
- REK-SØR: S-05308
- Conditions
- Labor, Obstetric
- Keywords
- Labor, instrumental delivery, nutrition, epidural anesthesia, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Aug 2006 (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 is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.
Detailed description
Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at gestational age > 36 weeks, parity 0
Key exclusion criteria (16 listed)
- Gestational age < 36 weeks
- Signs of fetal pathology:
- Maternal diseases and pregnancy complications
- CTG test: cardiotocographic test (a measure of fetal activity)
- PI: pulsatory index (velocity pattern)
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-containing soft drinkCommercial energy/sports drink | Dietary supplement | – |
Primary outcome
The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time
Time frame: At time of birth
4 secondary outcomes
Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
Use of epidural anesthetics
Use of contraction-stimulating drugs
Instrumental 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 6 Jul 2011.
Related trials for Labor, Obstetric
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Tore Henriksen, MD principal investigator
Oslo 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 Energy-containing soft drink in people with Labor, Obstetric, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 16 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 6 Jul 2011. 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 Norway. 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?
The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time (time frame: At time of birth). 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 Jul 2011.