NCT01349686

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

1 month

First QC Date

May 5, 2011

Last Update Submit

February 17, 2013

Conditions

Labor

Keywords

FoodFluidsLabor

Outcome Measures

Primary Outcomes (1)

  • Duration of labour (measured in minutes from admission to delivery)

    Two months

Secondary Outcomes (2)

  • Number of cesarean sections due to prolonged second stage of labour (measured in number of cases).

    Two months

  • Number of cases of bronchoaspiration.

    Two months

Study Arms (2)

Oral intake of fluids

EXPERIMENTAL

Intake of oral fluids during labour.

Procedure: Diet

Fasting

PLACEBO COMPARATOR

No intake of oral fluids during labour.

Procedure: Fasting

Interventions

DietPROCEDURE

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

Oral intake of fluids
FastingPROCEDURE

No intake of fluids during labour.

Fasting

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age \> 37 weeks.
  • Cervical dilation \< 5 cms.

You may not qualify if:

  • Maternal pathologies (diabetes, heart disease, preeclampsia)
  • Breech presentation or any other condition that is an indication of cesarean section.
  • Premature rupture of membranes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Interventions

DietAngptl4 protein, mouse

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jorge Espinosa, Resident

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

  • Osvaldo Reyes, Doctor

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Research

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 6, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

PA(1)