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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.

Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Duration of labour (measured in minutes from admission to delivery) [ Time Frame: Two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 5, 2011
Last Updated: February 17, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Food
Fluids
Labor

ClinicalTrials.gov processed this record on October 21, 2014