Clinical trial NCT03949166: Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
Official title: Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor and Delivery
Keywords: labor
delivery
eating
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 arms - fasting and eating
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: prolonged second stage of labor
timeFrame: the delivery
measure: duration of pushing
timeFrame: the delivery
measure: operative vaginal delivery
timeFrame: the delivery
measure: cesarean section
timeFrame: the delivery
Secondary outcomes:
measure: Maternal satisfaction
timeFrame: from 2 days after delivery until 6 months after the delivery , she will be asked once
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meor Medical hospital
Study officials:
affiliation: Meir Medical hospital
name: Gil Shechter Maor, MD
role: PRINCIPAL_INVESTIGATOR
References: