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Trial record 47 of 284 for:    Panama

Effect of Fluid Oral Intake During Labour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01349686
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

Condition or disease Intervention/treatment Phase
Labor Procedure: Diet Procedure: Fasting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Oral intake of fluids
Intake of oral fluids during labour.
Procedure: Diet
Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).

Placebo Comparator: Fasting
No intake of oral fluids during labour.
Procedure: Fasting
No intake of fluids during labour.

Primary Outcome Measures :
  1. Duration of labour (measured in minutes from admission to delivery) [ Time Frame: Two months ]

Secondary Outcome Measures :
  1. Number of cesarean sections due to prolonged second stage of labour (measured in number of cases). [ Time Frame: Two months ]
  2. Number of cases of bronchoaspiration. [ Time Frame: Two months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01349686

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Saint Thomas Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
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Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, Doctor Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama Identifier: NCT01349686    
Other Study ID Numbers: MHST2011-03
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama: