Effect of Fluid Oral Intake During Labour

NCT ID: NCT01349686

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral intake of fluids

Intake of oral fluids during labour.

Group Type EXPERIMENTAL

Diet

Intervention Type PROCEDURE

Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).

Fasting

No intake of oral fluids during labour.

Group Type PLACEBO_COMPARATOR

Fasting

Intervention Type PROCEDURE

No intake of fluids during labour.

Interventions

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Diet

Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).

Intervention Type PROCEDURE

Fasting

No intake of fluids during labour.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorge Espinosa, Resident

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Osvaldo Reyes, Doctor

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2011-03

Identifier Type: -

Identifier Source: org_study_id

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