Effect of Fluid Oral Intake During Labour

Labor Clinical Trial

Official title:

Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349686
• Other study ID #: MHST2011-03
• 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

• Labor

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