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临床试验/NCT05302401
NCT05302401Unknown不适用

Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level

Marmara University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Saliva cortisol level

研究概览

简要总结

This study aims to provide strong A-level evidence to the literature by supporting the maternal and fetal results of continuous midwife support together with saliva cortisol level measurements. As a result of this study, it is expected that women who receive intrapartum continuous midwife support and their babies have lower saliva cortisol levels than women in the control group, women who receive intrapartum continuous midwife support experience less fear, and women who receive intrapartum uninterrupted midwife support are expected to have lower intervention rates in their births. If the existing hypotheses are accepted, it is aimed to expand the practice of intrapartum continuous midwife support. Although pregnancy, childbirth and postpartum period are a physiological process, it is an important source of stress brought on by physical and hormonal changes for women's life. Uninterrupted midwife support in women who will give birth is associated with more vaginal births and fewer negative birth experiences. Uninterrupted midwife care also has higher female satisfaction, less intervention and lower maintenance costs. Therefore, evidence-based practices are needed to reduce the stress level of the woman during the intraparty period. In the study, the pregnancy diagnosis form will be applied by the researcher to the pregnant women in the experimental and control group between the 28th and 36th weeks of the outpatient clinic. Visual Analog Scale will be applied to determine the Wijma Birth Expectation/Experience (W-DEQ A) Scale and birth fear in order to determine the birth fears of pregnant women in the 28th-36th week. During outpatient checks, the first saliva cortisol samples will be taken by the scholar Meserret Aslan between 8:30 and 09:00 in the morning. By Bursiyer Meserret Aslan, six hours of online pregnancy training will be given to the pregnant women in the experimental group and uninterrupted midwife support will be provided during the intrapartum period. After birth, mother and newborn saliva cortisol samples will be repeated by the scholar Meserret Aslan within the first half hour of the postpartum from the experimental and control groups. Before postpartum discharge procedures take place between 24th and 72nd hours, a sample of mother and newborn saliva cortisol will be taken and stored under appropriate conditions (Refrigerator (2-8 °C) 4 Days) by Meserret Aslan, a scholar from the experimental and control groups. The Birth Experience Scale and the wijma birth expectancy/birth experience (W-DEQ B) scale will also be applied before discharge. The world health organization's maximum acceptable cesarean section rate is 53.1%. Turkey has the highest cesarean section rate among OECD countries. There are studies that show that continuous midwife support in childbirth is useful in reducing the rate of cesarean sections. In addition, it is foreseen that reducing the stress levels of women and their babies who are offered uninterrupted midwife support will contribute to the prevention of mental illness in the postpartum period, which is one of the most fragile periods for women's mental health. Intrapartum continuous midwife support, which will facilitate adaptation to the role of mother in the postpartum period, will also contribute to the mother and baby bonding that form the basis of mental health in the future life of the baby. This study is expected to contribute to improving maternal and infant health, as well as improving public mental health. Evidence-based information will be provided to investigate saliva cortisol levels and to demonstrate the importance of intrapartum continuous midwife support in reducing stress levels of women and their babies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who can speak and understand Turkish.
  • Women between the ages of 18 and
  • Women with their first pregnancy.
  • Women with the only living fetus.
  • Women who do not have any chronic diseases.
  • Women who live with their spouses.
  • Women who have not been diagnosed with risky pregnancy during pregnancy.
  • Women whose pregnancy is between 28 and 36 weeks.
  • Women who scored 38 or more on the Wijma Birth Experience/Expectation Scale A and agreed to participate voluntarily in the study.

排除标准

  • Women who do not complete all the steps of the research.
  • Those who develop any complications in the mother or baby during the birth process.
  • Those who do not complete the research forms will be excluded from the research.

结局指标

主要结局

Saliva cortisol level

时间窗: A salivary cortisol sample will be taken from the mother and baby within 24-72 hours after birth. This evaluation will take 1 week.

Saliva cortisol sample will be taken from prenatal pregnancy, mother and baby after birth to determine stress levels. The first saliva cortisol sample during pregnancy will be taken from the pregnant woman at the 28th-36th gestational week, and then the postpartum will be taken from both mother and baby within the first half hour. Finally, saliva cortisol test from mother and baby will be repeated within 24-72 hours before discharge.

次要结局

  • Level of fear of childbirth(The W-DEQ A scale will be applied to participants at least 12 weeks before birth. The W-DEQ B scale will be applied to participants within a maximum of 72 hours after birth. These evaluations will take 4 months.)
  • Birth experience(The Birth Experience Scale will be applied to participants within a maximum of 72 hours after birth. This evaluation will take 12 weeks.)
  • Stress level(The Visual Analog Scale should have been administered to the participants at least 12 weeks before birth. This assessment will take 12 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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