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

NCT03949166 | Unknown DMC

• 1 other identifier: MMC19-0258-17CTIL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor and Delivery

Keywords

labor; delivery; eating

Outcome Measures

Primary Outcomes (4)

• prolonged second stage of labor

  The mean time from full dilatation to the delivery of the baby on each group

  the delivery

• duration of pushing

  The mean time from beginning of pushing with the midwife to the delivery of the baby in each group

  the delivery

• operative vaginal delivery

  The mean incidence of operative vaginal delivery in each group

  the delivery

• cesarean section

  The mean incidence of cesarean section in each group

  the delivery

Secondary Outcomes (1)

• Maternal satisfaction

  from 2 days after delivery until 6 months after the delivery , she will be asked once

Study Arms (2)

Fasting

NO INTERVENTION

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.

Eating

EXPERIMENTAL

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

Interventions

food during labor and delivery OTHER

The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,

Eating

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meor Medical hospital

Kfar Saba, 4428164, Israel

RECRUITING

MeSH Terms

Interventions

Parturition

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Gil Shechter Maor, MD

  Meir Medical hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gil Shechter Maor, MD

CONTACT

972/543591626; gilshec@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are 2 arms - fasting and eating

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 14, 2019
• Study Start: December 18, 2018
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

IL (1)