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Date Consumption and Uterine Involution

Primary Purpose

Uterus Involution, Early Postpartum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Date Fruit
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterus Involution focused on measuring birth, date fruit, oxytocin, uterus involution

Eligibility Criteria

10 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sakarya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group

The group that was not attempted any intervention in the postpartum period

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2021
Last Updated
September 28, 2021
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05072769
Brief Title
Date Consumption and Uterine Involution
Official Title
The Effect of Date Consumption in the Early Postpartum Period on Uterine Involution
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus Involution, Early Postpartum Hemorrhage
Keywords
birth, date fruit, oxytocin, uterus involution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
There is no need for masking as placebo will not be applied.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
After the fetus and placenta are born, feeding 100 gr (5-6 pieces) dates to the experimental group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The group that was not attempted any intervention in the postpartum period
Intervention Type
Dietary Supplement
Intervention Name(s)
Date Fruit
Intervention Description
Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.
Primary Outcome Measure Information:
Title
Hemoglobin values
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.
Time Frame
6 hours
Title
Hematocrit values
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.
Time Frame
6 hours
Title
Oxytocin values
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.
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevser Özdemir, Dr
Phone
+90 264 295 66 24
Email
kevserozdemir@sakarya.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin Hamlacı Başkaya, Dr
Phone
+90 295 295 43 31
Email
yhamlaci@sakarya.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevser Özdemir, Dr
Organizational Affiliation
Sakarya University
Official's Role
Study Chair
Facility Information:
Facility Name
Sakarya University
City
Sakarya
ZIP/Postal Code
54050
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevser Özdemir, Dr
Phone
+90 264 295 66 24
Email
kevserozdemir@sakarya.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will be conducted with the data open to all researchers.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
The data obtained from the study will be shared after it is reported and published.
Citations:
PubMed Identifier
28286995
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.
Results Reference
result
PubMed Identifier
21280989
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.
Results Reference
result
PubMed Identifier
29033994
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.
Results Reference
result

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Date Consumption and Uterine Involution

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