Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
NCT ID: NCT03949166
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2018-12-18
2021-02-01
Brief Summary
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The objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms: Fasting arm, with the routine management of water and clear fluids or eating, she will be asked to eat every 2 hours or less a food from a list supplied by the study team.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
Detailed Description
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Prolonged fasting during labor can lead to execution of the patients making them tired and less tolerant to the pain, decreasing their ability to cooperate during the pushing phase. However, the recommendation to avoid eating has justified by the risk for unplanned cesarean section which is done under fasting. In general, cesarean sections are done under regional anesthesia but if there is a need for general anesthesia (due to pain or urgency), there is a risk for aspiration if the patient has not been fasting.
We also know that the stomach is clearing slower in the labor process, therefore some recommend fasting during labor.
In recent years there is a decrease in the use of general anesthesia during cesarean sections and since the incidence of aspiration during cesarean section is rare and due to the demand from the patients for autonomy and controlling their labor process including the option of eating the debate regarding eating during labor and delivery is justified.
In 2009 an ACOG(American College of Obstetricians and Gynecologists ) committee report concluded that there is not enough evidence regarding the link between drinking clear fluids and reflux , vomiting and aspiration during labor.
the objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.
Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.
The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms:
1. Fasting arm- The patient will be allowed to drink water and clear fluids as the routine management in our birthing center
2. Eating arm - The patient will be asked to eat every 2 hours or less a food from a list supplied by the study team, with no limitations on drinking.
The list of food was created with the anesthesiologist team according the review board demand.
The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fasting
After completion of an epidural block patients that agreed to participate in the study and were randomised to the fasting arm will be allowed to drink water and clear fluids during labor and delivery as accepted by the institute protocol.
No interventions assigned to this group
Eating
After completion of an epidural block patients that agreed to participate in the study and were randomized to the eating arm will be allowed to eat during their labor and delivery. They will be provided with the list of food that was approved and accepted by the anesthesia team. They will be asked to try eating every 2 hours but if they feel lack of need to eat or any side effects preventing them to eat they can choose not to eat. When reaching full dilatation of 10cm they will ber asked to stop eating.
food during labor and delivery
The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,
Interventions
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food during labor and delivery
The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,
Eligibility Criteria
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Inclusion Criteria
* After an epidural anaesthesia
Exclusion Criteria
* Known anomalies or chromosomal abnormalities
* Patient at increased risk for aspiration based on anesthesiologist assesment
* A patient post epidural anesthesia with pain indicating the need for a new epidural insertion
18 Years
45 Years
FEMALE
Yes
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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Gil Shechter Maor, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical hospital
Locations
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Meor Medical hospital
Kfar Saba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Shanny Hadar
Role: primary
Other Identifiers
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MMC19-0258-17CTIL
Identifier Type: -
Identifier Source: org_study_id