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Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome

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ClinicalTrials.gov Identifier: NCT03949166
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

The recommendations regarding eating and drinking during the labor and delivery process are not clear.

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.


Condition or disease Intervention/treatment Phase
Labor and Delivery Other: food during labor and delivery Not Applicable

Detailed Description:

Vaginal birth can be a prolonged process, especially during the first delivery. The recommendations regarding eating and drinking during the labor and delivery process are not clear. There is no agreement between the physicians regarding eating and drinking while being in labor in the birthing center. This disagreement is due to lack of research in this field and inconclusive results in previous studies.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are 2 arms - fasting and eating
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Other: 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,




Primary Outcome Measures :
  1. prolonged second stage of labor [ Time Frame: the delivery ]
    The mean time from full dilatation to the delivery of the baby on each group

  2. duration of pushing [ Time Frame: the delivery ]
    The mean time from beginning of pushing with the midwife to the delivery of the baby in each group

  3. operative vaginal delivery [ Time Frame: the delivery ]
    The mean incidence of operative vaginal delivery in each group

  4. cesarean section [ Time Frame: the delivery ]
    The mean incidence of cesarean section in each group


Secondary Outcome Measures :
  1. Maternal satisfaction [ Time Frame: from 2 days after delivery until 6 months after the delivery , she will be asked once ]
    The median satisfaction from the delivery of the mother of the delivery process from 1-11



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy at 37 weeks or more
  • After an epidural anaesthesia

Exclusion Criteria:

  • Preterm delivery before 37 weeks of pregnancy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949166


Contacts
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Contact: Gil Shechter Maor, MD 972/543591626 gilshec@gmail.com

Locations
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Israel
Meor Medical hospital Recruiting
Kfar Saba, Israel, 4428164
Contact: Shanny Hadar    97297471588    shanny.hadar@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Gil Shechter Maor, MD Meir Medical hospital
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03949166    
Other Study ID Numbers: MMC19-0258-17CTIL
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meir Medical Center:
labor
delivery
eating