Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 10:46 PM
Study NCT ID:
NCT05072769
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Date Consumption and Uterine Involution
Sponsor:
Sakarya University
Organization:
Study Overview
Official Title:
The Effect of Date Consumption in the Early Postpartum Period on Uterine Involution
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
The 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.
It will be held in the postpartum service of Sakarya University Training and Research Hospital between October - April 2021.
The 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.
It will be held in the postpartum service of Sakarya University Training and Research Hospital between October - April 2021.
Detailed Description:
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.
The 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.
It will be held in Sakarya University Training and Research Hospital delivery room and postpartum service between October - December 2021.
The 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).
Which 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.
The 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.
The 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.
It will be held in Sakarya University Training and Research Hospital delivery room and postpartum service between October - December 2021.
The 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).
Which 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.
The 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: