NCT03242356

Brief Summary

Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

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

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

August 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2017

Completed
Last Updated

April 13, 2018

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 4, 2017

Last Update Submit

April 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of parturients who declared to have ingested clear fluid during the labor.

    The survey will be completed within 2 hours following the delivery

Secondary Outcomes (10)

  • Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient

    The survey will be completed within 2 hours following the delivery

  • Specify the type of liquid ingested (water or sweet liquid) and its volume

    The survey will be completed within 2 hours following the delivery

  • Specify the frequency of ingestion of solid foods during labor

    The survey will be completed within 2 hours following the delivery

  • Assess the degree of discomfort associated with thirst that was felt during labor

    The survey will be completed within 2 hours following the delivery

  • Assess the degree of discomfort associated with hunger that was felt during labor

    The survey will be completed within 2 hours following the delivery

  • +5 more secondary outcomes

Interventions

Questionnaire focuses on : * oral intake of clear fluid during the labor * oral intake of solid meal during the labor * fasting duration for solid and liquids * instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …) * discomfort related to thirst during labor * discomfort related to hunger during labor We will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor

You may qualify if:

  • All adult woman who has been in labor in our hospital

You may not qualify if:

  • Patient refusal
  • Elective cesarean section, or emergency cesarean section in a woman not in labor
  • Intrauterine fetal death
  • Therapeutic abortion
  • Patient consent not available (for example, in case of severe post-partum hemorrhage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hopital Femme Mère Enfant

Bron, 69677, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

August 25, 2017

Primary Completion

November 25, 2017

Study Completion

November 25, 2017

Last Updated

April 13, 2018

Record last verified: 2017-08

Locations