PregnancyMaternal StresNCT07764380
Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy
A study testing Maternal Epigenetics Training Module in people with Pregnancy, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of stress management and epigenetic awareness training provided in prenatal classes on maternal stress levels, cortisol levels, and epigenetic awareness. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Maternal Epigenetics Training Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18 and older
- Pregnant women in any trimester of pregnancy
- Pregnant women who can read and understand Turkish
- Pregnant women who voluntarily agree to participate in the study
- Having a singleton pregnancy
- Pregnant women without a high-risk pregnancy
- Pregnant women who voluntarily participate in prenatal education classes will be included.
Who cannot join
- Foreign nationals with communication difficulties,
- Multiple pregnancies,
- Illiterate pregnant women,
- Migrant pregnant women who do not speak Turkish,
- Pregnant women with high-risk pregnancies,
- Pregnant women not enrolled in prenatal education programs,
- Pregnant women with intellectual disabilities,
- Pregnant women who refuse to participate in the study will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Emine Aksüt Akçay
Kahramanmaraş
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
Official title: Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy: A Randomized Controlled Trial on the Effectiveness of Educational Programs
The aim of this study is to evaluate the effects of stress management and epigenetic awareness training provided in prenatal classes on maternal stress levels, cortisol levels, and epigenetic awareness.
The main questions it aims to answer are:
- Do stress management and epigenetic awareness training provided in prenatal classes affect pregnant women's cortisol levels?
- Does the training affect pregnant women's knowledge and awareness of epigenetic effects?
Read the detailed description
The study sample will be selected using random sampling from among pregnant women who apply to the Prenatal Education Program at Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. The study was conducted using a quasi-experimental design with an experimental and control group, employing a pre-test-post-test approach. A portion of the pregnant women, selected through random assignment, will be included in the experimental group, while the remaining portion will be included in the control group. Data will be collected by the researcher through face-to-face interviews at the Prenatal Education School of Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. Each face-to-face interview will last approximately 15-30 minutes. The study will be conducted with two groups: the Maternal Epigenetic Education Module intervention group (intervention) and the control group.
Prior to the start of the educational program, pre-test data will be collected from participants in the intervention group by administering the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form. Additionally, saliva samples will be collected to determine participants' cortisol levels. The Maternal Epigenetic Education Module will be conducted over three weeks, consisting of a total of three sessions held once a week. The educational presentation will cover stress management, the potential effects of stress during pregnancy on the mother, the potential effects of stress during pregnancy on the fetus, epigenetic mechanisms, and the effects of the mother's lifestyle on fetal health. Following the completion of the training program, the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form will be administered again to obtain final test data, and saliva samples will be collected once more to measure cortisol levels. For participants in the control group, only two interviews will be conducted. During the first interview, the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form will be administered, and a saliva sample will be collected.
At the second follow-up visit, which will take place four weeks later, final data will be collected using the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form, and saliva samples will be collected again for cortisol measurement. The stress levels, epigenetic awareness levels, and cortisol levels of the pregnant women will be measured before and after the intervention.
- Conditions
- Pregnancy
- Being tested
- Maternal Epigenetics Training Module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Epigenetics Training ModuleBehavioural
The Maternal Epigenetics Education Module is a structured educational intervention designed to reduce stress levels in expectant mothers during pregnancy, raise their awareness of the effects of stress on both the mother and the fetus, and promote healthy lifestyle behaviors within the framework of epigenetic mechanisms. The module addresses the relationship between stress, epigenetics, and fetal health during pregnancy from a scientific perspective and aims to equip expectant mothers with basic skills for managing stress.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | The Maternal Epigenetics Training Module will be conducted over a three-week period, consisting of a total of three sessions held once a week. The training will include an informational presentation covering stress management, the potential effects of stress during pregnancy on the mother, the potential effects of stress during pregnancy on the fetus, epigenetic mechanisms, and the impact of the mother's lifestyle on fetal health. Receives: Behavioral: Maternal Epigenetics Training Module |
| Control | No intervention | The standard group that did not participate in the Maternal Epigenetics Training Module. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pregnancy-Related Stress
The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.
Measured: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (day 1)
Assessment of Pregnancy-Related Stress
The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.
Measured: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
Secondary outcomes (4)
Measuring pregnant women's awareness of epigenetic effects and stress
This is a short questionnaire developed by the researcher to measure pregnant women's awareness of epigenetic effects and stress. It was designed to determine the level of awareness regarding the impact of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the education provided, and was prepared by the researcher to assess the effect of maternal stress on epigenetic awareness. This form is designed to measure pregnant women's awareness of the effects of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the level of awareness regarding the education provided at the Prenatal Education Program (Nowak et al., 2020). It will be evaluated based on the pregnant women's experiences and knowledge over the past month.
Measured: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (day 1)
Measuring pregnant women's awareness of epigenetic effects and stress
This is a short questionnaire developed by the researcher to measure pregnant women's awareness of epigenetic effects and stress. It was designed to determine the level of awareness regarding the impact of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the education provided, and was prepared by the researcher to assess the effect of maternal stress on epigenetic awareness. This form is designed to measure pregnant women's awareness of the effects of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the level of awareness regarding the education provided at the Prenatal Education Program (Nowak et al., 2020). It will be evaluated based on the pregnant women's experiences and knowledge over the past month.
Measured: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
Cortisol level measurement
Cortisol levels will be measured using saliva samples from pregnant women. Cortisol samples will be collected on an empty stomach between 8:00 and 9:00 a.m., and two samples will be collected from each participant-one before the training and one after the training.
Measured: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (day 1)
Cortisol level measurement
Cortisol levels will be measured using saliva samples from pregnant women. Cortisol samples will be collected on an empty stomach between 8:00 and 9:00 a.m., and two samples will be collected from each participant-one before the training and one after the training.
Measured: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start15 May 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Randomized controlled trial conducted with experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aksut Akcay, Kahramanmaras Sutcu Imam University
- Investigators
- ESRA KARATAŞ OKYAY, PhD, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764380
- Sponsor's protocol ID
- KSUESRAKARATASOKYAY007
- Acronym
- Maternal Stres
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dieckmann L, Czamara D. Epigenetics of prenatal stress in humans: the current research landscape. Clin Epigenetics. 2024 Feb 2;16(1):20. doi: 10.1186/s13148-024-01635-9.
PubMed 38308342
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy: A Randomized Controlled Trial on the Effectiveness of Educational Programs
- ClinicalTrials.gov ID
- NCT07764380
- Acronym / sponsor ID
- Maternal Stres / KSUESRAKARATASOKYAY007
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Aug 2026 (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.
The aim of this study is to evaluate the effects of stress management and epigenetic awareness training provided in prenatal classes on maternal stress levels, cortisol levels, and epigenetic awareness.
The main questions it aims to answer are:
- Do stress management and epigenetic awareness training provided in prenatal classes affect pregnant women's cortisol levels?
- Does the training affect pregnant women's knowledge and awareness of epigenetic effects?
Detailed description
The study sample will be selected using random sampling from among pregnant women who apply to the Prenatal Education Program at Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. The study was conducted using a quasi-experimental design with an experimental and control group, employing a pre-test-post-test approach. A portion of the pregnant women, selected through random assignment, will be included in the experimental group, while the remaining portion will be included in the control group. Data will be collected by the researcher through face-to-face interviews at the Prenatal Education School of Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. Each face-to-face interview will last approximately 15-30 minutes. The study will be conducted with two groups: the Maternal Epigenetic Education Module intervention group (intervention) and the control group.
Prior to the start of the educational program, pre-test data will be collected from participants in the intervention group by administering the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form. Additionally, saliva samples will be collected to determine participants' cortisol levels. The Maternal Epigenetic Education Module will be conducted over three weeks, consisting of a total of three sessions held once a week. The educational presentation will cover stress management, the potential effects of stress during pregnancy on the mother, the potential effects of stress during pregnancy on the fetus, epigenetic mechanisms, and the effects of the mother's lifestyle on fetal health. Following the completion of the training program, the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form will be administered again to obtain final test data, and saliva samples will be collected once more to measure cortisol levels. For participants in the control group, only two interviews will be conducted. During the first interview, the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form will be administered, and a saliva sample will be collected.
At the second follow-up visit, which will take place four weeks later, final data will be collected using the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form, and saliva samples will be collected again for cortisol measurement. The stress levels, epigenetic awareness levels, and cortisol levels of the pregnant women will be measured before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: Maternal Epigenetics Training ModuleThe Maternal Epigenetics Training Module will be conducted over a three-week period, consisting of a total of three sessions held once a week. The training will include an informational presentation covering stress management, the potential effects of stress during pregnancy on the mother, the potential effects of stress during pregnancy on the fetus, epigenetic mechanisms, and the impact of the mother's lifestyle on fetal health. |
| Control | No intervention | –The standard group that did not participate in the Maternal Epigenetics Training Module. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women aged 18 and older
- Pregnant women in any trimester of pregnancy
- Pregnant women who can read and understand Turkish
- Pregnant women who voluntarily agree to participate in the study
- Having a singleton pregnancy
Key exclusion criteria (8 listed)
- Foreign nationals with communication difficulties,
- Multiple pregnancies,
- Illiterate pregnant women,
- Migrant pregnant women who do not speak Turkish,
- Pregnant women with high-risk pregnancies,
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 |
|---|---|---|
| Maternal Epigenetics Training ModuleThe Maternal Epigenetics Education Module is a structured educational intervention designed to reduce stress levels in expectant mothers during pregnancy, raise their awareness of the effects of stress on both the mother and the fetus, and promote healthy lifestyle behaviors within the framework of epigenetic mechanisms. The module addresses the relationship between stress, epigenetics, and fetal health during pregnancy from a scientific perspective and aims to equip expectant mothers with basic skills for managing stress. | Behavioural | Education group |
Primary outcome
Assessment of Pregnancy-Related Stress
Time frame: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (day 1)
The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.
Assessment of Pregnancy-Related Stress
Time frame: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.
4 secondary outcomes
Measuring pregnant women's awareness of epigenetic effects and stress
Time frame: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (day 1)
Measuring pregnant women's awareness of epigenetic effects and stress
Time frame: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
Cortisol level measurement
Time frame: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (day 1)
Cortisol level measurement
Time frame: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 38308342Dieckmann L, Czamara D. Epigenetics of prenatal stress in humans: the current research landscape. Clin Epigenetics. 2024 Feb 2;16(1):20. doi: 10.1186/s13148-024-01635-9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
ESRA KARATAŞ OKYAY, PhD study chair
Kahramanmaras Sutcu Imam University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Epigenetics Training Module in people with Pregnancy, run by Kahramanmaras Sutcu Imam University at 2 sites 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İsmail Gürkan Çıkım, Professor ((344) 310-0000, ismailgurkancikim@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pregnancy-Related Stress (time frame: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764380, which also lists 1 linked publication.
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 13 Aug 2026.