Effect of Fluid Oral Intake During Labour

This study has been completed.
Sponsor:
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

May 5, 2011
February 17, 2013
September 2011
October 2011   (final data collection date for primary outcome measure)
Duration of labour (measured in minutes from admission to delivery) [ Time Frame: Two months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01349686 on ClinicalTrials.gov Archive Site
  • Number of cesarean sections due to prolonged second stage of labour (measured in number of cases). [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Number of cases of bronchoaspiration. [ Time Frame: Two months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Fluid Oral Intake During Labour
Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Labor
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
348
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Panama
 
NCT01349686
MHST2011-03
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, Doctor Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP