Effect of Fluid Oral Intake During Labour

Tracking Information
First Submitted Date ICMJE	May 5, 2011
First Posted Date ICMJE	May 6, 2011
Last Update Posted Date	February 20, 2013
Study Start Date ICMJE	September 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 5, 2011)	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; (submitted: May 5, 2011)	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 ]
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Labor
Intervention ICMJE	Procedure: Diet Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).; Procedure: Fasting No intake of fluids during labour.
Study Arms	Experimental: Oral intake of fluids Intake of oral fluids during labour. Intervention: Procedure: Diet; Placebo Comparator: Fasting No intake of oral fluids during labour. Intervention: Procedure: Fasting
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
Actual Enrollment ICMJE; (submitted: May 5, 2011)	348
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Gestational age > 37 weeks.; Cervical dilation < 5 cms. Exclusion Criteria: Maternal pathologies (diabetes, heart disease, preeclampsia); Breech presentation or any other condition that is an indication of cesarean section.; Premature rupture of membranes.
Sex/Gender	Sexes Eligible for Study: 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
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	Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama Principal Investigator: Osvaldo Reyes, Doctor Saint Thomas Hospital, Panama
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