Effect of Fluid Oral Intake During Labour

February 17, 2013 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of labour (measured in minutes from admission to delivery)
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of cesarean sections due to prolonged second stage of labour (measured in number of cases).
Time Frame: Two months
Two months
Number of cases of bronchoaspiration.
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

  • Principal Investigator: Osvaldo Reyes, Doctor, Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (ESTIMATE)

May 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 17, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MHST2011-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor

Clinical Trials on Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe