Labor Clinical Trial
Official title:
Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Panama | Saint Thomas Hospital | Panama |
Lead Sponsor | Collaborator |
---|---|
Saint Thomas Hospital, Panama |
Panama,
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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