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Effect of Fluid Oral Intake During Labour

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349686
First Posted: May 6, 2011
Last Update Posted: February 20, 2013
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.
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
  Purpose
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 Intervention
Labor Procedure: Diet Procedure: Fasting

Study Type: Interventional
Study Design: 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.

Further study details as provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 348
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01349686


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

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01349686     History of Changes
Other Study ID Numbers: MHST2011-03
First Submitted: May 5, 2011
First Posted: May 6, 2011
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Food
Fluids
Labor