PregnantNCT06239753
The Impact of Dynamic Neuromuscular Stabilization on Pregnancy
A study testing Dynamic Neuromuscular Stabilization and Standard Prenatal Education Program Implementation in people with Pregnant and Exercise, run by Dondu Kurnaz at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to determine the pregnancy and childbirth outcomes of using the DNS method to facilitate anatomical and physiological adaptations during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Dynamic Neuromuscular Stabilization and Standard Prenatal Education Program Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2024to 2 Jul 2025
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparity
- Singleton Pregnancy
- Gestational Age Between 11-13 Weeks
- Age Between 20-35 Years
- Body Mass Index in the Range of 18-30
- Receiving Pregnancy Check-ups at the Hospital where the Research is Conducted
Who cannot join
- Presence of a heart condition affecting hemodynamics
- History of restrictive lung disease
- Multiple pregnancies
- Severe anemia
- Movement-restricting musculoskeletal system anomalies
Trial locations and contacts
1 site in 1 country.
Deniz Akyıldız, Doç. Dr. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lütfi Kırdar Şehir Hastanesi
Istanbul
Dödü Kuraz
About this study
Official title: The Effect of Dynamic Neuromuscular Stabilization Applied in the Second Trimester of Pregnancy on Pregnancy: A Randomized Controlled Study
The aim of this randomized controlled study is to determine the pregnancy and childbirth outcomes of using the DNS method to facilitate anatomical and physiological adaptations during pregnancy.
Read the detailed description
During pregnancy, significant anatomical and physiological changes occur as the baby grows inside the uterus. As pregnancy progresses, body mass index increases, the uterus expands towards the abdominal cavity, and the woman's center of gravity shifts. This change in the center of gravity leads to a backward shift in the trunk, hyperextension of the knees, and the formation of lumbar lordosis, thoracic kyphosis, and pelvic curvature. The increased weight can cause pelvic floor collapse and weakness in pelvic floor muscles, leading to urinary incontinence, pelvic organ prolapse, fecal incontinence, sexual dysfunction, and pelvic pain.
Proper management of the body during this period can not only facilitate childbirth but also reduce potential problems that may arise during pregnancy. Exercises play a crucial role in managing the body correctly during pregnancy. Aerobic exercises, strength training, and specific Kegel exercises are commonly performed during pregnancy. However, despite the frequent occurrence of musculoskeletal and postural changes during pregnancy, it is observed that postural exercises to regulate these changes are not widely implemented. Studies have indicated that stabilization exercises are more effective than traditional strength exercises in reducing complaints during pregnancy.
There is a lack of sufficient research in the literature on core stabilization related to posture alignment during pregnancy. Core stabilization is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimal force production, transfer, and movement of the extremities. It is essential to prevent excessive load on the pelvis, spine, and kinetic chain. When this system functions effectively, loads on the body are distributed evenly, reducing excess load on the joints of the kinetic chain. Core strength training primarily focuses on strengthening deep core muscles, especially the multifidus and transversus abdominis muscles, which may weaken during pregnancy. Current exercise programs for pregnant women include exercises targeting core muscles, such as Pilates, antigravity fitness, birth support belts, stability balls, and Dynamic Neuromuscular Stabilization (DNS). Although studies on the benefits of stabilization exercises during pregnancy are available in the literature, there is no specific research on the application of DNS during pregnancy.
DNS is a system that emphasizes coordination and strength, focusing on the overall harmony of the body and foundational stability. It is based on developmental kinesiology models. DNS encompasses motor patterns and programs that infants inherently possess, allowing them to develop ideal posture, functional joint centering, optimal respiration, and locomotor skills during ontogenesis. The main goal is to restore physiological movement patterns defined by developmental kinesiology DNS has been widely accepted in clinical practice as a method that provides balanced subcortical or reflexive core stabilization, coordinating diaphragm, transversus abdominis, internal oblique, multifidus, and pelvic floor coactivation with intra-abdominal pressure and coordinated activation of superficial abdominal muscles.
Understanding the physiological and anatomical adaptations during pregnancy is crucial for the pregnant woman to cope with the increased metabolic demands vital for the developing fetus and meet the requirements of childbirth. Recognizing pathological deviations in pregnant women and ensuring core stabilization using appropriate methods are essential to optimize outcomes for both the mother and the baby. In the context of critically ill pregnant women, the DNS method can be used effectively during pregnancy, taking into account that different modifications may be needed to optimize their treatment. Well-designed studies are needed to determine the effectiveness of the DNS method.
- Being tested
- Dynamic Neuromuscular Stabilization, Standard Prenatal Education Program Implementation
- Keywords
- Pregnancy, Stabilization, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Neuromuscular StabilizationBehavioural
Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes. Application of Dynamic Neuromuscular Stabilization (DNS).
Standard Prenatal Education Program ImplementationBehavioural
Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Neuromuscular Stabilization Applied | Experimental | Intervention Group I will receive DNS (Dynamic Neuromuscular Stabilization) applications in the hospital, led by a physiotherapist, once a week for 10 weeks. During each session, participants will be instructed to perform the DNS exercises at home and take notes. They will receive reminders via short message service (SMS) to practice the exercises at home. The DNS application for pregnant women involves checking the breathing pattern before starting exercises in all sessions. Pregnant women will be instructed to breathe through the nose, and if they find it challenging to maintain nasal breathing, the Body Oxygen Level Test (BOLT) score will be measured. If the BOLT score is low, guidance will be provided on how to increase it by adjusting the breathing technique." Receives: Behavioral: Dynamic Neuromuscular Stabilization |
| Standard Prenatal Education Program Implementation | Experimental | The group will receive the standard prenatal education program, consisting of 5 sessions of general education and 2 sessions of standard pregnancy exercises and respiratory exercises, as part of the hospital's prenatal education program. The educational topics will include one-hour sessions on pregnancy and nutrition, postpartum care and family planning, baby care and infant massage, breastfeeding and lactation education, and first aid for infants, under the headings of childbirth and coping methods for labor pain Receives: Behavioral: Standard Prenatal Education Program Implementation |
| Control | No intervention | The control group will consist of pregnant women attending routine examinations at the hospital's maternity clinic. As per hospital policy, routine breastfeeding education is provided after the 32nd week during regular prenatal check-ups at the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Measurements
Pelvic floor muscle measurements will be assessed by a specialist in obstetrics and gynecology using transperineal ultrasonography. The Voluson 730 Pro ultrasound device will be used for assessment. A standard bladder filling protocol will be implemented before measurements. For this, women will be instructed to drink 600-750 ml of water one hour before the evaluation and refrain from emptying their bladders until the end of the test. Women will be positioned on their backs with knees flexed at 60°, and a pillow will be placed under their head. The ultrasound transducer will be placed suprapubically in the caudo-posterior direction to visualize the posterior inferior aspect of the bladder in the transverse plane during the first rest period. A first marker will be placed at the base of the bladder during this resting period. Women will be asked to contract their pelvic floor muscles during the assessment. The ultrasound image will be frozen during this contraction, and a second marker
Measured: Between the 11th and 36th weeks of pregnancy,
The Pittsburgh Sleep Quality Index
Assessing sleep quality over the past month, the PSQI consists of a total of 24 questions. The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality. The scale will be applied twice, for the first and last application.
Measured: Between the 11th and 36th weeks of pregnancy,
State-Trait Anxiety Inventory
Aims to measure individuals' levels of state and trait anxiety. The scale consists of two subscales, each comprising 20 items. An increase in scores from the scale indicates a higher level of anxiety. The scale will be applied twice, for the first and last application. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The average score level determined in the applications varies between 36 and 41.
Measured: Between the 11th and 36th weeks of pregnancy,
Oswestry Skalası
The questionnaire related to lower back pain consisting of a total of 10 questions, each with 6 options. The scale assigns a minimum score of 0 and a maximum score of 5 to each question. The overall possible score ranges from 0 to 50. An increase in the total score collected from the questionnaire indicates a worsening of the pain condition. The scale will be applied twice, for the first and last application.
Measured: Between the 11th and 36th weeks of pregnancy,
Multidimensional Scale of Perceived Social Support
The questionnaire based on the subjective evaluation of social support received from family, friends, and significant others in individuals' social environments. The questionnaire examines three dimensions: family, friends, and significant others, totaling 48 questions with four questions evaluating each dimension. Each item in the scale is rated on a 7-point Likert scale ranging from strongly disagree to strongly agree. Scores obtained from the three separate dimensions are summed to calculate subscale scores, and the total scale score is obtained by summing the scores from all subscales. Higher scores from both the scale and its subscales indicate a higher perceived level of social support. The scale will be applied twice, for the first and last application. The score that can be obtained from the scale varies between 7 and 84.
Measured: Between the 11th and 36th weeks of pregnancy,
The Fatigue Severity Scale
The Fatigue Severity Scale (FSS) was developed by Krupp et al. in 1989. The scale consists of a total of 9 items, and each item is rated on a scale of 1-7 (1=strongly disagree, 7=strongly agree). The total score is obtained by dividing the sum of scores by the number of scale items. The possible total score ranges from 9 to 63, and when divided by the number of items, the lowest possible score is 1, while the highest is 7. A higher score indicates an increased level of fatigue. The scale will be applied twice, for the first and last application.
Measured: Between the 11th and 36th weeks of pregnancy,
Pregnancy Weight Gain
The weight of the pregnant woman will be measured at her first application and at her last application using the scale currently used for pregnant women.
Measured: Between the 11th and 36th weeks of pregnancy,
Secondary outcomes (2)
Blood pressure arterial (mmHg)
Blood pressure will be measured at the pregnant woman's first application and at her last application using the blood pressure monitor currently used for pregnant women.
Measured: Between the 11th and 36th weeks of pregnancy,
pulse rate measurements
During the initial visit and the final visit, pulse rate measurements will be manually performed by the attending healthcare personnel.
Measured: Between the 11th and 36th weeks of pregnancy,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start23 Jul 2024
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dondu Kurnaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dondu Kurnaz, Lütfi Kırdar City Hospital
- Investigators
- Elif Ünlügedik Sayın, Dr., Principal investigator, KLKŞHSunahan Koyuncu, Ftrp, Study chair, KLKŞHDöndü Kurnaz, Study director, KLKŞHDeniz Akyıldız, Study chair, Sütçü İmam Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239753
- Sponsor's protocol ID
- KLKŞH
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All researchers will only access data within the scope of their respective roles.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Neuromuscular Stabilization Applied in the Second Trimester of Pregnancy on Pregnancy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06239753
- Acronym / sponsor ID
- KLKŞH
- Keywords
- Pregnancy, Stabilization, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Dondu KurnazUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 2 Feb 2024 (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 randomized controlled study is to determine the pregnancy and childbirth outcomes of using the DNS method to facilitate anatomical and physiological adaptations during pregnancy.
Detailed description
During pregnancy, significant anatomical and physiological changes occur as the baby grows inside the uterus. As pregnancy progresses, body mass index increases, the uterus expands towards the abdominal cavity, and the woman's center of gravity shifts. This change in the center of gravity leads to a backward shift in the trunk, hyperextension of the knees, and the formation of lumbar lordosis, thoracic kyphosis, and pelvic curvature. The increased weight can cause pelvic floor collapse and weakness in pelvic floor muscles, leading to urinary incontinence, pelvic organ prolapse, fecal incontinence, sexual dysfunction, and pelvic pain.
Proper management of the body during this period can not only facilitate childbirth but also reduce potential problems that may arise during pregnancy. Exercises play a crucial role in managing the body correctly during pregnancy. Aerobic exercises, strength training, and specific Kegel exercises are commonly performed during pregnancy. However, despite the frequent occurrence of musculoskeletal and postural changes during pregnancy, it is observed that postural exercises to regulate these changes are not widely implemented. Studies have indicated that stabilization exercises are more effective than traditional strength exercises in reducing complaints during pregnancy.
There is a lack of sufficient research in the literature on core stabilization related to posture alignment during pregnancy. Core stabilization is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimal force production, transfer, and movement of the extremities. It is essential to prevent excessive load on the pelvis, spine, and kinetic chain. When this system functions effectively, loads on the body are distributed evenly, reducing excess load on the joints of the kinetic chain. Core strength training primarily focuses on strengthening deep core muscles, especially the multifidus and transversus abdominis muscles, which may weaken during pregnancy. Current exercise programs for pregnant women include exercises targeting core muscles, such as Pilates, antigravity fitness, birth support belts, stability balls, and Dynamic Neuromuscular Stabilization (DNS). Although studies on the benefits of stabilization exercises during pregnancy are available in the literature, there is no specific research on the application of DNS during pregnancy.
DNS is a system that emphasizes coordination and strength, focusing on the overall harmony of the body and foundational stability. It is based on developmental kinesiology models. DNS encompasses motor patterns and programs that infants inherently possess, allowing them to develop ideal posture, functional joint centering, optimal respiration, and locomotor skills during ontogenesis. The main goal is to restore physiological movement patterns defined by developmental kinesiology DNS has been widely accepted in clinical practice as a method that provides balanced subcortical or reflexive core stabilization, coordinating diaphragm, transversus abdominis, internal oblique, multifidus, and pelvic floor coactivation with intra-abdominal pressure and coordinated activation of superficial abdominal muscles.
Understanding the physiological and anatomical adaptations during pregnancy is crucial for the pregnant woman to cope with the increased metabolic demands vital for the developing fetus and meet the requirements of childbirth. Recognizing pathological deviations in pregnant women and ensuring core stabilization using appropriate methods are essential to optimize outcomes for both the mother and the baby. In the context of critically ill pregnant women, the DNS method can be used effectively during pregnancy, taking into account that different modifications may be needed to optimize their treatment. Well-designed studies are needed to determine the effectiveness of the DNS method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dynamic Neuromuscular Stabilization Applied | Experimental | Behavioral: Dynamic Neuromuscular StabilizationIntervention Group I will receive DNS (Dynamic Neuromuscular Stabilization) applications in the hospital, led by a physiotherapist, once a week for 10 weeks. During each session, participants will be instructed to perform the DNS exercises at home and take notes. They will receive reminders via short message service (SMS) to practice the exercises at home. The DNS application for pregnant women involves checking the breathing pattern before starting exercises in all sessions. Pregnant women will be instructed to breathe through the nose, and if they find it challenging to maintain nasal breathing, the Body Oxygen Level Test (BOLT) score will be measured. If the BOLT score is low, guidance will be provided on how to increase it by adjusting the breathing technique." |
| Standard Prenatal Education Program Implementation | Experimental | Behavioral: Standard Prenatal Education Program ImplementationThe group will receive the standard prenatal education program, consisting of 5 sessions of general education and 2 sessions of standard pregnancy exercises and respiratory exercises, as part of the hospital's prenatal education program. The educational topics will include one-hour sessions on pregnancy and nutrition, postpartum care and family planning, baby care and infant massage, breastfeeding and lactation education, and first aid for infants, under the headings of childbirth and coping methods for labor pain |
| Control | No intervention | –The control group will consist of pregnant women attending routine examinations at the hospital's maternity clinic. As per hospital policy, routine breastfeeding education is provided after the 32nd week during regular prenatal check-ups at the hospital. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparity
- Singleton Pregnancy
- Gestational Age Between 11-13 Weeks
- Age Between 20-35 Years
- Body Mass Index in the Range of 18-30
Key exclusion criteria (5 listed)
- Presence of a heart condition affecting hemodynamics
- History of restrictive lung disease
- Multiple pregnancies
- Severe anemia
- Movement-restricting musculoskeletal system anomalies
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 |
|---|---|---|
| Dynamic Neuromuscular StabilizationConducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes. Application of Dynamic Neuromuscular Stabilization (DNS). | Behavioural | Dynamic Neuromuscular Stabilization Applied |
| Standard Prenatal Education Program ImplementationConducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes. | Behavioural | Standard Prenatal Education Program Implementation |
Primary outcome
Pelvic Floor Muscle Measurements
Time frame: Between the 11th and 36th weeks of pregnancy,
Pelvic floor muscle measurements will be assessed by a specialist in obstetrics and gynecology using transperineal ultrasonography. The Voluson 730 Pro ultrasound device will be used for assessment. A standard bladder filling protocol will be implemented before measurements. For this, women will be instructed to drink 600-750 ml of water one hour before the evaluation and refrain from emptying their bladders until the end of the test. Women will be positioned on their backs with knees flexed at 60°, and a pillow will be placed under their head. The ultrasound transducer will be placed suprapubically in the caudo-posterior direction to visualize the posterior inferior aspect of the bladder in the transverse plane during the first rest period. A first marker will be placed at the base of the bladder during this resting period. Women will be asked to contract their pelvic floor muscles during the assessment. The ultrasound image will be frozen during this contraction, and a second marker
The Pittsburgh Sleep Quality Index
Time frame: Between the 11th and 36th weeks of pregnancy,
Assessing sleep quality over the past month, the PSQI consists of a total of 24 questions. The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality. The scale will be applied twice, for the first and last application.
State-Trait Anxiety Inventory
Time frame: Between the 11th and 36th weeks of pregnancy,
Aims to measure individuals' levels of state and trait anxiety. The scale consists of two subscales, each comprising 20 items. An increase in scores from the scale indicates a higher level of anxiety. The scale will be applied twice, for the first and last application. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The average score level determined in the applications varies between 36 and 41.
Oswestry Skalası
Time frame: Between the 11th and 36th weeks of pregnancy,
The questionnaire related to lower back pain consisting of a total of 10 questions, each with 6 options. The scale assigns a minimum score of 0 and a maximum score of 5 to each question. The overall possible score ranges from 0 to 50. An increase in the total score collected from the questionnaire indicates a worsening of the pain condition. The scale will be applied twice, for the first and last application.
Multidimensional Scale of Perceived Social Support
Time frame: Between the 11th and 36th weeks of pregnancy,
The questionnaire based on the subjective evaluation of social support received from family, friends, and significant others in individuals' social environments. The questionnaire examines three dimensions: family, friends, and significant others, totaling 48 questions with four questions evaluating each dimension. Each item in the scale is rated on a 7-point Likert scale ranging from strongly disagree to strongly agree. Scores obtained from the three separate dimensions are summed to calculate subscale scores, and the total scale score is obtained by summing the scores from all subscales. Higher scores from both the scale and its subscales indicate a higher perceived level of social support. The scale will be applied twice, for the first and last application. The score that can be obtained from the scale varies between 7 and 84.
The Fatigue Severity Scale
Time frame: Between the 11th and 36th weeks of pregnancy,
The Fatigue Severity Scale (FSS) was developed by Krupp et al. in 1989. The scale consists of a total of 9 items, and each item is rated on a scale of 1-7 (1=strongly disagree, 7=strongly agree). The total score is obtained by dividing the sum of scores by the number of scale items. The possible total score ranges from 9 to 63, and when divided by the number of items, the lowest possible score is 1, while the highest is 7. A higher score indicates an increased level of fatigue. The scale will be applied twice, for the first and last application.
Pregnancy Weight Gain
Time frame: Between the 11th and 36th weeks of pregnancy,
The weight of the pregnant woman will be measured at her first application and at her last application using the scale currently used for pregnant women.
2 secondary outcomes
Blood pressure arterial (mmHg)
Time frame: Between the 11th and 36th weeks of pregnancy,
pulse rate measurements
Time frame: Between the 11th and 36th weeks of pregnancy,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No. All researchers will only access data within the scope of their respective roles.
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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.
Deniz Akyıldız, Doç. Dr. contact
Elif Ünlügedik Sayın, Dr. principal investigator
KLKŞH
Sunahan Koyuncu, Ftrp study chair
KLKŞH
Döndü Kurnaz study director
KLKŞH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Neuromuscular Stabilization and Standard Prenatal Education Program Implementation in people with Pregnant and Exercise, run by Dondu Kurnaz 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 6 inclusion and 5 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 26 Aug 2024. 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?
Contact Döndü Kurnaz, Dr (5052381105, zsk2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Measurements (time frame: Between the 11th and 36th weeks of pregnancy,). The study lists 7 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 26 Aug 2024.