An interventional study of Date Fruit in Uterus Involution and Early Postpartum Hemorrhage, sponsored by Sakarya University. Status unknown at 1 site in Turkey. Open to female participants aged 10 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Sakarya University · Not applicable, Interventional, and Prevention
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's planned enrollment of 60 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group
Dietary Supplement: Date Fruit
The group that was not attempted any intervention in the postpartum period
Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.
Hemoglobin values
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.
Time frame: 6 hours
Hematocrit values
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.
Time frame: 6 hours
Oxytocin values
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.
Time frame: 6 hours
Plan to share: Yes — The study will be conducted with the data open to all researchers.
Supporting information: Study protocol, Sap, Icf, Csr
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sakarya University