Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT05072769
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Date Consumption and Uterine Involution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002910', 'term': 'Chronology as Topic'}], 'ancestors': [{'id': 'D013995', 'term': 'Time'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There is no need for masking as placebo will not be applied.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be an experimental and a control group. Dates will be given to the experimental group after the birth, while the control group will be treated in line with the hospital routines.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin values', 'timeFrame': '6 hours', 'description': 'Approximately 500 ml of blood is lost in vaginal delivery. Blood loss exceeding 500 ml in the postpartum period is a sign of bleeding. therefore, the involution process will be defined with the changes in hemoglobin (gr/dl) immediately after birth and 6 hours after birth.'}, {'measure': 'Hematocrit values', 'timeFrame': '6 hours', 'description': 'More than 10% decrease in the postpartum period compared to the prenatal period indicates bleeding. Therefore, the hematocrit (gr/dl) changes immediately after birth and 6 hours after birth will define the involution process.'}, {'measure': 'Oxytocin values', 'timeFrame': '6 hours', 'description': 'Oxytocin, which is produced in the hypothalamus and enters the circulation from the posterior pituitary, is a hormone that prevents postpartum hemorrhage by regulating the intensity and rhythm of postpartum uterine contractions. For this reason, the involution process will be defined by looking at oxytocin releases immediately after birth and 6 hours after birth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['birth', 'date fruit', 'oxytocin', 'uterus involution'], 'conditions': ['Uterus Involution', 'Early Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '28286995', 'type': 'RESULT', 'citation': 'Razali N, Mohd Nahwari SH, Sulaiman S, Hassan J. Date fruit consumption at term: Effect on length of gestation, labour and delivery. J Obstet Gynaecol. 2017 Jul;37(5):595-600. doi: 10.1080/01443615.2017.1283304. Epub 2017 Mar 13.'}, {'pmid': '21280989', 'type': 'RESULT', 'citation': 'Al-Kuran O, Al-Mehaisen L, Bawadi H, Beitawi S, Amarin Z. The effect of late pregnancy consumption of date fruit on labour and delivery. J Obstet Gynaecol. 2011;31(1):29-31. doi: 10.3109/01443615.2010.522267.'}, {'pmid': '29033994', 'type': 'RESULT', 'citation': 'Kordi M, Meybodi FA, Tara F, Fakari FR, Nemati M, Shakeri M. Effect of Dates in Late Pregnancy on the Duration of Labor in Nulliparous Women. Iran J Nurs Midwifery Res. 2017 Sep-Oct;22(5):383-387. doi: 10.4103/ijnmr.IJNMR_213_15.'}]}, 'descriptionModule': {'briefSummary': 'There are many studies in the literature examining the effects of dates on pregnancy, birth and postpartum processes. However, no study has been found that examines the effect of women on the involution process in the early postpartum period. It is thought that this study will fill the gap in the literature with this study, which was conducted to determine the effect of date fed to women in the early postpartum period on uterine involution.\n\nThe study was planned as a randomized controlled and experimental study to determine the effect of date fed to women in the early postpartum period on uterine involution.\n\nIt will be held in the postpartum service of Sakarya University Training and Research Hospital between October - April 2021.', 'detailedDescription': 'There are many studies in the literature examining the effects of dates on pregnancy, birth and postpartum processes. However, no study has been found that examines the effect of women on the involution process in the early postpartum period. It is thought that this study will fill the gap in the literature with this study, which was conducted to determine the effect of date fed to women in the early postpartum period on uterine involution.\n\nThe study was planned as a randomized controlled and experimental study to determine the effect of date fed to women in the early postpartum period on uterine involution.\n\nIt will be held in Sakarya University Training and Research Hospital delivery room and postpartum service between October - December 2021.\n\nThe universe of the study will be women who gave vaginal birth between October and December 2021 in the delivery room and puerperal service department of Sakarya University Training and Research Hospital, and the sample will be 60 women (30 experimental group-30 control group).\n\nWhich of the women forming the sample group will be included in the experimental/intervention and control groups will be determined by simple randomization. A "random number generation program (research randomizer)" will be used in the randomization of the sample, and randomization with this program will be done by an unbiased researcher who is not involved in the research.\n\nThe implementation phase of the research will start after the third stage of labor (after the fetus and its appendages are born) ends. After the mother is stabilized, the "Descriptive Demographic Information Form" will be filled in for the experimental and control groups, and then blood samples will be taken from the mothers in order to determine the hemoglobin, hematocrit and oxytocin values. Since the blood sample will be taken from the intravenous line opened for emergencies during labor, an additional invasive procedure will not be applied to the patients. After the first blood sample is taken, 100gr (5-6 pieces) of Deglet Noor dates will be given to the experimental group and asked to be consumed within one hour. At this stage, the practices will continue in accordance with the hospital routines for the mothers in the control group. At the 6th hour after the third stage of labor, blood samples will be taken again to determine the hemoglobin, hematocrit and oxytocin values, and the application will end. In the postpartum ward, where the study will be conducted, routine blood samples are taken at the 6th hour after birth, so invasive intervention will be avoided.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer to participate in the research,\n* Primiparous,\n* Not induction during birth,\n* Born at term and healthy (38-42 weeks old, born 2500-4000gr, born with 5th minute apgar 7 and above, no known congenital disease),\n* Not given oxytocin in the postpartum period,\n* No oral intake restriction after controlling for postpartum uterine involution,\n* Over 18 years of age who gave vaginal birth,\n* It is planned to include mothers who can speak Turkish.\n\nExclusion Criteria:\n\n* Not willing to participate in the research,\n* Risk of postpartum bleeding in the first hour after delivery,\n* Having a health problem in which the mother or baby is at risk,\n* Not breastfeeding her baby\n* Having a disease that prevents breastfeeding,\n* Those whose hemoglobin value is below 10 g/dl,\n* Cesarean delivery,\n* Have a blood disease,\n* The baby was taken to the neonatal intensive care unit,\n* It is planned not to include mothers with diabetes.'}, 'identificationModule': {'nctId': 'NCT05072769', 'briefTitle': 'Date Consumption and Uterine Involution', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'The Effect of Date Consumption in the Early Postpartum Period on Uterine Involution', 'orgStudyIdInfo': {'id': '48535046780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group', 'interventionNames': ['Dietary Supplement: Date Fruit']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The group that was not attempted any intervention in the postpartum period'}], 'interventions': [{'name': 'Date Fruit', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54050', 'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kevser Özdemir, Dr', 'role': 'CONTACT', 'email': 'kevserozdemir@sakarya.edu.tr', 'phone': '+90 264 295 66 24'}], 'facility': 'Sakarya University', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'centralContacts': [{'name': 'Kevser Özdemir, Dr', 'role': 'CONTACT', 'email': 'kevserozdemir@sakarya.edu.tr', 'phone': '+90 264 295 66 24'}, {'name': 'Yasemin Hamlacı Başkaya, Dr', 'role': 'CONTACT', 'email': 'yhamlaci@sakarya.edu.tr', 'phone': '+90 295 295 43 31'}], 'overallOfficials': [{'name': 'Kevser Özdemir, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Sakarya University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be collected in the first hour and sixth hour after patients give birth. It will be reported after reaching the entire sample group.', 'ipdSharing': 'YES', 'description': 'The study will be conducted with the data open to all researchers.', 'accessCriteria': 'The data obtained from the study will be shared after it is reported and published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dr. Kevser Ozdemir', 'investigatorAffiliation': 'Sakarya University'}}}}