Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT03949166
Status:
UNKNOWN
Last Update Posted:
2019-11-29
First Post:
2019-05-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D036801', 'term': 'Parturition'}], 'ancestors': [{'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 2 arms - fasting and eating'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2019-05-12', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prolonged second stage of labor', 'timeFrame': 'the delivery', 'description': 'The mean time from full dilatation to the delivery of the baby on each group'}, {'measure': 'duration of pushing', 'timeFrame': 'the delivery', 'description': 'The mean time from beginning of pushing with the midwife to the delivery of the baby in each group'}, {'measure': 'operative vaginal delivery', 'timeFrame': 'the delivery', 'description': 'The mean incidence of operative vaginal delivery in each group'}, {'measure': 'cesarean section', 'timeFrame': 'the delivery', 'description': 'The mean incidence of cesarean section in each group'}], 'secondaryOutcomes': [{'measure': 'Maternal satisfaction', 'timeFrame': 'from 2 days after delivery until 6 months after the delivery , she will be asked once', 'description': 'The median satisfaction from the delivery of the mother of the delivery process from 1-11'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor', 'delivery', 'eating'], 'conditions': ['Labor and Delivery']}, 'descriptionModule': {'briefSummary': "The recommendations regarding eating and drinking during the labor and delivery process are not clear.\n\nThe objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.\n\nPatients 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.\n\nThe 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.\n\nThe list of food was created with the anesthesiologist team according the review board demand.\n\nThe 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.", 'detailedDescription': "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.\n\nProlonged 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.\n\nWe also know that the stomach is clearing slower in the labor process, therefore some recommend fasting during labor.\n\nIn 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.\n\nIn 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.\n\nthe objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.\n\nPatients 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.\n\nThe 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:\n\n1. Fasting arm- The patient will be allowed to drink water and clear fluids as the routine management in our birthing center\n2. 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.\n\nThe list of food was created with the anesthesiologist team according the review board demand.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy at 37 weeks or more\n* After an epidural anaesthesia\n\nExclusion Criteria:\n\n* Preterm delivery before 37 weeks of pregnancy\n* Known anomalies or chromosomal abnormalities\n* Patient at increased risk for aspiration based on anesthesiologist assesment\n* A patient post epidural anesthesia with pain indicating the need for a new epidural insertion'}, 'identificationModule': {'nctId': 'NCT03949166', 'briefTitle': 'Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome', 'orgStudyIdInfo': {'id': 'MMC19-0258-17CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Fasting', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Eating', 'description': '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.', 'interventionNames': ['Other: food during labor and delivery']}], 'interventions': [{'name': 'food during labor and delivery', 'type': 'OTHER', 'description': 'The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,', 'armGroupLabels': ['Eating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4428164', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shanny Hadar', 'role': 'CONTACT', 'email': 'shanny.hadar@clalit.org.il', 'phone': '97297471588'}], 'facility': 'Meor Medical hospital', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Gil Shechter Maor, MD', 'role': 'CONTACT', 'email': 'gilshec@gmail.com', 'phone': '972/543591626'}], 'overallOfficials': [{'name': 'Gil Shechter Maor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}