Labor ComplicationNCT05302401
Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level
A study testing intrapartum uninterrupted midwife support in people with Labor Complication and Midwife, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication, Midwife, Stress
- What is being tested?
- intrapartum uninterrupted midwife support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Labor Complication, Midwife, Stress, Labor Pain
- Being tested
- intrapartum uninterrupted midwife support
- Keywords
- Continuous midwife support, Midwife, Labour support, Stress, Neonatal, Intrapartum, Cortisol, Saliva
- Medical subject headings
- Obstetric Labor Complications, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrapartum uninterrupted midwife supportBehavioural
Also called Prenatal education
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 in the prenatal period to determine the fear of childbirth. There are questions on the scale that include labor pains and how to feel, feelings when the baby is born, thoughts about childbirth within a month. It is planned to apply the W-DEQ-A scale to pregnant women who are in the 28th-36th week of pregnancy. In the postpartum period, the W-DEQ-B scale will be applied to determine the fear of childbirth. As the score increases, the fear of childbirth experienced by women increases. It is recommended to apply it at least 2 hours after birth and within 15 days at the latest. In this study, postpartum is planned to be applied within 24-72 hours.
Measured: 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
Visual Analog Scale (VAS) is a 10-point measurement tool and participants express the stress they perceive subjectively. This scale measures the stress that the person reports. "0" is expressed as not stressed at all, "10" is expressed as being stressed at the highest possible level.
Measured: 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 used to measure the birth experience. This scale is a 9-point self-assessment scale. The scale includes substances related to the birth experience and evaluates mothers' perception of stress, pain, control, fear and support during childbirth.It is planned to apply the birth experience scale to mothers within 24-72 hours.
Measured: The Birth Experience Scale will be applied to participants within a maximum of 72 hours after birth. This evaluation will take 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302401
- Sponsor's protocol ID
- M_aslan
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level
- ClinicalTrials.gov ID
- NCT05302401
- Acronym / sponsor ID
- M_aslan
- Conditions
- Labor Complication, Midwife, Stress, Labor Pain
- Keywords
- Continuous midwife support, Midwife, Labour support, Stress, Neonatal, Intrapartum, Cortisol, Saliva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women receiving uninterrupted midwife support during the intrapartum period | Experimental | Behavioral: intrapartum uninterrupted midwife support28. - 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrapartum uninterrupted midwife supportAlso: Prenatal educationPrenatal 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.) | Behavioural | Women receiving uninterrupted midwife support during the intrapartum period |
Primary outcome
Saliva cortisol level
Time frame: 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 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.
Saliva cortisol level
Time frame: 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 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.
Saliva cortisol level
Time frame: 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.
3 secondary outcomes
Level of fear of childbirth
Time frame: 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
Time frame: 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
Time frame: The Birth Experience Scale will be applied to participants within a maximum of 72 hours after birth. This evaluation will take 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrapartum uninterrupted midwife support in people with Labor Complication and Midwife, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva cortisol level (time frame: A salivary cortisol sample will be taken from each participant at the entrance to the delivery room. This evaluation will take 1 week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.