LaborNCT01349686
Effect of Fluid Oral Intake During Labour
A study testing Diet and Fasting in people with Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor
- What is being tested?
- Diet and Fasting
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 sitePanama
- Study dates
- Sep 2011to Oct 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age > 37 weeks.
- Cervical dilation < 5 cms.
Who cannot join
- Maternal pathologies (diabetes, heart disease, preeclampsia)
- Breech presentation or any other condition that is an indication of cesarean section.
- Premature rupture of membranes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.
Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Besides, there are several studies that suggest that food intake during labour can be associated with shorter labours and a lower cesarean rate. The aim of the investigators study is to show if the oral intake of fluids during labour can reduce the first stage of labour with minimum risk to the patient.
- Conditions
- Labor
- Being tested
- Diet, Fasting
- Keywords
- Food, Fluids, Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietProcedure or surgery
Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).
FastingProcedure or surgery
No intake of fluids during labour.
| Study group | Role | What they receive |
|---|---|---|
| Oral intake of fluids | Experimental | Intake of oral fluids during labour. Receives: Procedure: Diet |
| Fasting | Placebo comparator | No intake of oral fluids during labour. Receives: Procedure: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labour (measured in minutes from admission to delivery)
Measured: Two months
Secondary outcomes (2)
Number of cesarean sections due to prolonged second stage of labour (measured in number of cases).
Measured: Two months
Number of cases of bronchoaspiration.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Jorge Espinosa, Resident, Principal investigator, Saint Thomas Hospital, PanamaOsvaldo Reyes, Doctor, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349686
- Sponsor's protocol ID
- MHST2011-03
- Status last verified
- Feb 2013
- First submitted
- 5 May 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01349686
- Acronym / sponsor ID
- MHST2011-03
- Conditions
- Labor
- Keywords
- Food, Fluids, Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 May 2011 (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.
Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Besides, there are several studies that suggest that food intake during labour can be associated with shorter labours and a lower cesarean rate. The aim of the investigators study is to show if the oral intake of fluids during labour can reduce the first stage of labour with minimum risk to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral intake of fluids | Experimental | Procedure: DietIntake of oral fluids during labour. |
| Fasting | Placebo comparator | Procedure: FastingNo intake of oral fluids during labour. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age > 37 weeks.
- Cervical dilation < 5 cms.
Key exclusion criteria (3 listed)
- Maternal pathologies (diabetes, heart disease, preeclampsia)
- Breech presentation or any other condition that is an indication of cesarean section.
- Premature rupture of membranes.
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 |
|---|---|---|
| DietOral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar). | Procedure or surgery | Oral intake of fluids |
| FastingNo intake of fluids during labour. | Procedure or surgery | Fasting |
Primary outcome
Duration of labour (measured in minutes from admission to delivery)
Time frame: Two months
2 secondary outcomes
Number of cesarean sections due to prolonged second stage of labour (measured in number of cases).
Time frame: Two months
Number of cases of bronchoaspiration.
Time frame: Two months
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 20 Feb 2013.
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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.
Jorge Espinosa, Resident principal investigator
Saint Thomas Hospital, Panama
Osvaldo Reyes, Doctor principal investigator
Saint Thomas Hospital, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Fasting in people with Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 inclusion and 3 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 20 Feb 2013. 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 Panama. 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?
Duration of labour (measured in minutes from admission to delivery) (time frame: Two months). 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 20 Feb 2013.