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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01349686
Other study ID # MHST2011-03
Secondary ID
Status Completed
Phase N/A
First received May 5, 2011
Last updated February 17, 2013
Start date September 2011
Est. completion date October 2011

Study information

Verified date February 2013
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority Panama: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 348
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Diet
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 fluids during labour.

Locations

Country Name City State
Panama Saint Thomas Hospital Panama

Sponsors (1)

Lead Sponsor Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of labour (measured in minutes from admission to delivery) Two months No
Secondary Number of cesarean sections due to prolonged second stage of labour (measured in number of cases). Two months No
Secondary Number of cases of bronchoaspiration. Two months Yes
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