Date Consumption and Uterine Involution

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Date Consumption in the Early Postpartum Period on Uterine Involution

Conditions
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Uterus Involution, Early Postpartum Hemorrhage

Intervention / Treatment
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* Dietary Supplement: Date Fruit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in the research, Primiparous, Not induction during birth, Born at term and healthy (38-42 weeks old, born 2500-4000gr, born with 5th minute apgar 7 and above, no known congenital disease), Not given oxytocin in the postpartum period, No oral intake restriction after controlling for postpartum uterine involution, Over 18 years of age who gave vaginal birth, It is planned to include mothers who can speak Turkish. Exclusion Criteria: Not willing to participate in the research, Risk of postpartum bleeding in the first hour after delivery, Having a health problem in which the mother or baby is at risk, Not breastfeeding her baby Having a disease that prevents breastfeeding, Those whose hemoglobin value is below 10 g/dl, Cesarean delivery, Have a blood disease, The baby was taken to the neonatal intensive care unit, It is planned not to include mothers with diabetes.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group | Dietary Supplement: Date Fruit<br>* Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.<br>|
| No Intervention: Control group<br>The group that was not attempted any intervention in the postpartum period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth, date fruit, oxytocin, uterus involution