Effect of Fluid Oral Intake During Labour
This study has been completed.
Sponsor:
Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01349686
First received: May 5, 2011
Last updated: February 17, 2013
Last verified: February 2013
| Tracking Information | |||||||
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| First Received Date ICMJE | May 5, 2011 | ||||||
| Last Updated Date | February 17, 2013 | ||||||
| Start Date ICMJE | September 2011 | ||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Duration of labour (measured in minutes from admission to delivery) [ Time Frame: Two months ] [ Designated as safety issue: No ] | ||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | Complete list of historical versions of study NCT01349686 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effect of Fluid Oral Intake During Labour | ||||||
| Official Title ICMJE | Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial. | ||||||
| Brief 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. 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase | Not Provided | ||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Labor | ||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Enrollment ICMJE | 348 | ||||||
| Completion Date | October 2011 | ||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||
| Ages | Child, Adult, Senior | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Panama | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01349686 | ||||||
| Other Study ID Numbers ICMJE | MHST2011-03 | ||||||
| Has Data Monitoring Committee | No | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | Osvaldo A. Reyes T., Saint Thomas Hospital, Panama | ||||||
| Study Sponsor ICMJE | Saint Thomas Hospital, Panama | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| Information Provided By | Saint Thomas Hospital, Panama | ||||||
| Verification Date | February 2013 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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