Clinical trial NCT05302401: Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level
Official title: Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Complication
Midwife
Stress
Labor Pain
Keywords: Continuous midwife support
Midwife
Labour support
Stress
Neonatal
Intrapartum
Cortisol
Saliva
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-03-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women who can speak and understand Turkish.
* Women between the ages of 18 and 35.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Saliva cortisol level
timeFrame: A salivary cortisol sample will be taken from each participant at the entrance to the delivery room. This evaluation will take 1 week.
measure: Saliva cortisol level
timeFrame: A salivary cortisol sample will be taken from the mother and baby in the first half hour after birth. This evaluation will take 1 week.
measure: Saliva cortisol level
timeFrame: A salivary cortisol sample will be taken from the mother and baby within 24-72 hours after birth. This evaluation will take 1 week.
Secondary outcomes:
measure: Level of fear of childbirth
timeFrame: 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.
measure: Stress level
timeFrame: The Visual Analog Scale should have been administered to the participants at least 12 weeks before birth. This assessment will take 12 weeks.
measure: Birth experience
timeFrame: The Birth Experience Scale will be applied to participants within a maximum of 72 hours after birth. This evaluation will take 12 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Meserret ASLAN
state: Altindağ
Study officials:
References: