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临床试验/NCT05072769
NCT05072769Unknown不适用

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

Sakarya University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Hemoglobin values

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

There is no need for masking as placebo will not be applied.

入排标准

年龄范围
10 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Hemoglobin values

时间窗: 6 hours

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

时间窗: 6 hours

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

时间窗: 6 hours

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.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kevser Ozdemir

PhD

Sakarya University

研究点 (2)

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