NCT05302401

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 30, 2022

Last Update Submit

March 21, 2022

Conditions

Labor ComplicationMidwifeStressLabor Pain

Keywords

Continuous midwife supportMidwifeLabour supportStressNeonatalIntrapartumCortisolSaliva

Outcome Measures

Primary Outcomes (3)

  • Saliva cortisol level

    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.

    A salivary cortisol sample will be taken from each participant at the entrance to the delivery room. This evaluation will take 1 week.

  • Saliva cortisol level

    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.

    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.

  • Saliva cortisol level

    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.

    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 (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Women receiving uninterrupted midwife support during the intrapartum period

EXPERIMENTAL

28\. - 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 36th week. During outpatient checks, the first saliva cortisol samples will be taken by researcher Meserret Aslan between 8:30 and 09:00 in the morning. Researcher Meserret Aslan will provide six hours of online pregnancy training to pregnant women in the experimental group and provide uninterrupted midwife support during the intrapartum period.Within the first half hour of postpartum after birth, saliva cortisol samples of women will be repeated by researcher Meserret Aslan. Between the 24th and 72nd hours before postpartum discharge procedures take place, saliva cortisol samples of women will be taken for the last time by researcher Meserret Aslan from the experimental group.

Behavioral: intrapartum uninterrupted midwife support

Women who do not receive uninterrupted midwife support during the intrapartum period

NO INTERVENTION

Between the 28th and 36th weeks, the pregnancy diagnosis form will be applied by the researcher to the pregnant women in the control group. 28. - 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 36th week. During outpatient checks, the first saliva cortisol samples will be taken by researcher Meserret Aslan between 8:30 and 09:00 in the morning. After birth, postpartum from control groups will be repeated by researcher Meserret Aslan in the first half hour. Between the 24th and 72nd hours before postpartum discharge procedures take place, saliva cortisol samples of women will be taken for the last time by researcher Meserret Aslan from the control groups.

Interventions

intrapartum uninterrupted midwife supportBEHAVIORAL

Prenatal women will be trained about the birth process and psychological and physical support will be provided to women during childbirth. Among these supports, healthy women will be exercised during the labor action, given positions that facilitate childbirth, their hands will be held when they need them, their oral intake will not be restricted, and warm showers will be applied according to their wishes. (These applications can be increased.)

Also known as: Prenatal education
Women receiving uninterrupted midwife support during the intrapartum period

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meserret ASLAN

Ankara, Altindağ, 06080, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Obstetric Labor ComplicationsLabor Pain

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2022

First Posted

March 31, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)