Effect of Fluid Oral Intake During Labour
This study has been completed.
Sponsor:
Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01349686
First Posted: May 6, 2011
Last Update Posted: February 20, 2013
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 5, 2011 | ||||||
| First Posted Date ICMJE | May 6, 2011 | ||||||
| Last Update Posted Date | February 20, 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 ] | ||||||
| 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 |
|
||||||
| 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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE | Labor | ||||||
| Intervention ICMJE |
|
||||||
| Study Arms |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| 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:
|
||||||
| Sex/Gender |
|
||||||
| 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 | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | 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 |
|
||||||
| PRS Account | Saint Thomas Hospital, Panama | ||||||
| Verification Date | February 2013 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||