Ultrasonography PrenatalNCT06282419
The Effect of Visual and Audio Stimulus Offered to Father-to-be
A study testing USE OF MOBILE ULTRASOUND and ultrasound image taken from the internet in people with Ultrasonography Prenatal, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography Prenatal
- What is being tested?
- USE OF MOBILE ULTRASOUND and ultrasound image taken from the internet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2023to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Criteria for inclusion of pregnant women in the study:
- Being literate
- Being nulliparous
- 32-35. weeks of pregnancy between
- Having a single fetus
- There is no obstacle to vaginal birth
Show all 16Show fewer
- There is no condition that prevents breastfeeding
- Being open to communication
- Volunteering to participate in the research
- Criteria for inclusion of fathers in the study:
- Being literate
- Being over 18 years of age
- Being a father for the first time
- Using a smartphone
- Being open to communication
- Volunteering to participate in the research
Who cannot join
- Criteria for excluding pregnant women from the study:
- Illiteracy
- Having a high risk pregnancy
- Having a diagnosed psychiatric disease
- Exclusion criteria for women in the postpartum period from the study:
- Having given birth prematurely
Show all 13Show fewer
- Having had a caesarean section
- Development of complications in the mother and/or baby after birth
- A condition that prevents breastfeeding in the mother and/or baby
- Criteria for not including fathers in the study:
- Illiteracy
- Being under 18 years of age
- Having a diagnosed psychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk University
Erzurum
Merve Çakıl, +905310854245, mervecakil92@gmail.com
Ayla KANBUR, aylakanbur28@hotmail.com
About this study
Official title: The Effect of Visual and Auditory Stimuli Presented to Expectant Fathers on Mothers' Postpartum Breastfeeding Success, Perception of Partner Support and Postpartum Depression
It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program.
Read the detailed description
Data were collected by the researcher. The research was conducted in 2 stages. First stage; Women and their partners who meet the research criteria are at the 32-35th week of pregnancy. was included in the study during the week. First, introductory information forms were applied to the women and expectant fathers assigned to the experimental and control groups using the face-to-face interview technique.
Then, fetal images and fetal heart sounds were recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images of their babies, taken with a portable USG device, and fetal heart sounds were sent to the expectant fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). To the prospective fathers in experimental group 2, fetal USG images and fetal heart sounds taken from the internet, which were not of their babies, were sent by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). At this stage, no intervention was made to the fathers in the control group.
In the second stage of the research; Breastfeeding videos prepared by the researcher were sent to the fathers in experimental groups 1 and 2 via WhatsApp application twice a week for 4 weeks after birth. At this stage, no intervention was made to the fathers in the control group.
At the end of the 4th postpartum week, the women in the experimental groups and the control group were given the Spouse Support Scale Perceived by Women in the Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale by preparing a Google survey and sending the survey link via WhatsApp application. were provided to fill out.
Likewise, at the end of the 4th postpartum week, the fathers in the experimental groups and the control group were asked to fill out the Fathers; Breastfeeding Attitude and Participation Scale and the Edinburgh Postpartum Depression Scale via a Google survey, and the survey link was sent via WhatsApp application.
Taking USG images: They were taken and recorded by the researcher with a portable USG device. The researcher received a certificate by attending the midwife USG usage course.
Taking fetal heart sounds: They were taken and recorded by the researcher with a portable USG device.
Videos on breastfeeding: Prepared by the research team.
- Conditions
- Ultrasonography Prenatal
- Being tested
- USE OF MOBILE ULTRASOUND, ultrasound image taken from the internet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USE OF MOBILE ULTRASOUNDOther
First stage; Women and their partners who meet the research criteria are at the 32-35th week of pregnancy. was included in the study during the week. First, introductory information forms will be applied to the women and expectant fathers assigned to the experimental and control groups through face-to-face interview technique.
Then, fetal images and fetal heart sounds will be recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images and fetal heart sounds taken with the portable USG device of their babies will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp twice a week for 4 weeks after birth.
ultrasound image taken from the internetOther
First stage; Fetal USG images and fetal heart sounds, not belonging to their babies, taken from the internet, will be sent to the fathers in experimental group 2 via WhatsApp application by the researcher twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp application twice a week for 4 weeks after birth.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Fetal images and fetal heart sound recordings will be taken from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images of their babies, taken with a portable USG device, and fetal heart sounds will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). Receives: Other: USE OF MOBILE ULTRASOUND |
| Experimental group 2 | Placebo comparator | Fetal USG images and fetal heart sounds taken from the internet, which are not of their babies, will be sent to the prospective fathers by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers in experimental group 2 twice a week for 4 weeks after birth via WhatsApp application. Receives: Other: ultrasound image taken from the internet |
| control group | No intervention | No visual or auditory stimuli were sent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form (For Women)
The introductory information form prepared by the researchers consists of 16 questions about the introductory characteristics of women.
Measured: 30 days after birth
Spouse Support Scale Perceived by Women During Early Postpartum Period
The sub-dimensions are named "emotional support" (7 items), "social support" (6 items) and "physical support" (3 items). In the items, 1 was taken as "strongly disagree", 2 as "disagree", 3 as "undecided", 4 as "agree", and 5 as "strongly agree". In negative question items, 1 was taken as "strongly agree", 2 as "agree", 3 as "undecided", 4 as "disagree", and 5 as "strongly disagree".
Measured: 30 days after birth
Breastfeeding Self-Efficacy Scale-Short Form
This scale, which consists of a total of 14 items, is a 5-point Likert type and is evaluated as not at all sure (1 point) and always sure (5 points). The lowest score that can be obtained from the scale is 14 and the highest score is 70. The scale has no cut-off point; a higher score means higher breastfeeding self-efficacy.
Measured: 30 days after birth
Breastfeeding Adaptation Scale
The scale consists of 8 sub-dimensions and 27 items. Scale items are rated on a 5-point Likert scale between 1 point and 5 points (1 point: Strongly disagree, 2 points: Disagree, 3 points: Undecided, 4 points: Agree, 5 points: Strongly agree). Three items in the 6th sub-dimension of the scale, "Discomfort in Breastfeeding", contain negative statements and are rated as 1 (strongly agree) and 5 (strongly disagree). The minimum score that can be obtained from the scale is 27 and the maximum score is 135.
Measured: 30 days after birth
Edinburgh Postpartum Depression Scale
It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 12/13, and women whose total scale score is higher than the cut-off point are considered to be in the risk group.
Measured: 30 days after birth
Introductory Information Form (For Men)
The introductory information form prepared by the researchers consists of 5 questions about the personal characteristics of men.
Measured: 30 days after birth
Fathers' Breastfeeding Attitude and Participation Scale
It consists of a total of 28 items. In this scale, responses are evaluated on a five-point Likert scale: "1 = Strongly disagree", "2 = Disagree", "3 = Undecided", "4 = Agree" and "5 = Strongly agree". The total score to be obtained from the BET subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are considered positive attitudes, and those <58 are considered negative attitudes. The total score to be obtained from the BEK subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are called good participation, and those with <58 are called poor participation.
Measured: 30 days after birth
Edinburgh Postpartum Depression Scale for Men
It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 9/10, and men whose total scale score is higher than the cut-off point are considered to be in the risk group.
Measured: 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start21 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography PrenatalStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Parallel groups
- Model description
- This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Cakil, Ataturk University
- Investigators
- Ayla KANBUR, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282419
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/542
- Status last verified
- May 2024
- First submitted
- 2 Feb 2024
- Last updated
- 17 May 2024
- 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual and Auditory Stimuli Presented to Expectant Fathers on Mothers' Postpartum Breastfeeding Success, Perception of Partner Support and Postpartum Depression
- ClinicalTrials.gov ID
- NCT06282419
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/542
- Conditions
- Ultrasonography Prenatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 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.
It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program.
Detailed description
Data were collected by the researcher. The research was conducted in 2 stages. First stage; Women and their partners who meet the research criteria are at the 32-35th week of pregnancy. was included in the study during the week. First, introductory information forms were applied to the women and expectant fathers assigned to the experimental and control groups using the face-to-face interview technique.
Then, fetal images and fetal heart sounds were recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images of their babies, taken with a portable USG device, and fetal heart sounds were sent to the expectant fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). To the prospective fathers in experimental group 2, fetal USG images and fetal heart sounds taken from the internet, which were not of their babies, were sent by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). At this stage, no intervention was made to the fathers in the control group.
In the second stage of the research; Breastfeeding videos prepared by the researcher were sent to the fathers in experimental groups 1 and 2 via WhatsApp application twice a week for 4 weeks after birth. At this stage, no intervention was made to the fathers in the control group.
At the end of the 4th postpartum week, the women in the experimental groups and the control group were given the Spouse Support Scale Perceived by Women in the Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale by preparing a Google survey and sending the survey link via WhatsApp application. were provided to fill out.
Likewise, at the end of the 4th postpartum week, the fathers in the experimental groups and the control group were asked to fill out the Fathers; Breastfeeding Attitude and Participation Scale and the Edinburgh Postpartum Depression Scale via a Google survey, and the survey link was sent via WhatsApp application.
Taking USG images: They were taken and recorded by the researcher with a portable USG device. The researcher received a certificate by attending the midwife USG usage course.
Taking fetal heart sounds: They were taken and recorded by the researcher with a portable USG device.
Videos on breastfeeding: Prepared by the research team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound.
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Other: USE OF MOBILE ULTRASOUNDFetal images and fetal heart sound recordings will be taken from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images of their babies, taken with a portable USG device, and fetal heart sounds will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). |
| Experimental group 2 | Placebo comparator | Other: ultrasound image taken from the internetFetal USG images and fetal heart sounds taken from the internet, which are not of their babies, will be sent to the prospective fathers by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers in experimental group 2 twice a week for 4 weeks after birth via WhatsApp application. |
| control group | No intervention | –No visual or auditory stimuli were sent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Being literate
- Being nulliparous
- 32-35. weeks of pregnancy between
- Having a single fetus
- There is no obstacle to vaginal birth
Key exclusion criteria (13 listed)
- Criteria for excluding pregnant women from the study:
- Having given birth prematurely
- Having had a caesarean section
- Development of complications in the mother and/or baby after birth
- A condition that prevents breastfeeding in the mother and/or baby
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 |
|---|---|---|
| USE OF MOBILE ULTRASOUNDFirst stage; Women and their partners who meet the research criteria are at the 32-35th week of pregnancy. was included in the study during the week. First, introductory information forms will be applied to the women and expectant fathers assigned to the experimental and control groups through face-to-face interview technique. Then, fetal images and fetal heart sounds will be recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images and fetal heart sounds taken with the portable USG device of their babies will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp twice a week for 4 weeks after birth. | Other | Experimental group 1 |
| ultrasound image taken from the internetFirst stage; Fetal USG images and fetal heart sounds, not belonging to their babies, taken from the internet, will be sent to the fathers in experimental group 2 via WhatsApp application by the researcher twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp application twice a week for 4 weeks after birth. | Other | Experimental group 2 |
Primary outcome
Introductory Information Form (For Women)
Time frame: 30 days after birth
The introductory information form prepared by the researchers consists of 16 questions about the introductory characteristics of women.
Spouse Support Scale Perceived by Women During Early Postpartum Period
Time frame: 30 days after birth
The sub-dimensions are named "emotional support" (7 items), "social support" (6 items) and "physical support" (3 items). In the items, 1 was taken as "strongly disagree", 2 as "disagree", 3 as "undecided", 4 as "agree", and 5 as "strongly agree". In negative question items, 1 was taken as "strongly agree", 2 as "agree", 3 as "undecided", 4 as "disagree", and 5 as "strongly disagree".
Breastfeeding Self-Efficacy Scale-Short Form
Time frame: 30 days after birth
This scale, which consists of a total of 14 items, is a 5-point Likert type and is evaluated as not at all sure (1 point) and always sure (5 points). The lowest score that can be obtained from the scale is 14 and the highest score is 70. The scale has no cut-off point; a higher score means higher breastfeeding self-efficacy.
Breastfeeding Adaptation Scale
Time frame: 30 days after birth
The scale consists of 8 sub-dimensions and 27 items. Scale items are rated on a 5-point Likert scale between 1 point and 5 points (1 point: Strongly disagree, 2 points: Disagree, 3 points: Undecided, 4 points: Agree, 5 points: Strongly agree). Three items in the 6th sub-dimension of the scale, "Discomfort in Breastfeeding", contain negative statements and are rated as 1 (strongly agree) and 5 (strongly disagree). The minimum score that can be obtained from the scale is 27 and the maximum score is 135.
Edinburgh Postpartum Depression Scale
Time frame: 30 days after birth
It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 12/13, and women whose total scale score is higher than the cut-off point are considered to be in the risk group.
Introductory Information Form (For Men)
Time frame: 30 days after birth
The introductory information form prepared by the researchers consists of 5 questions about the personal characteristics of men.
Fathers' Breastfeeding Attitude and Participation Scale
Time frame: 30 days after birth
It consists of a total of 28 items. In this scale, responses are evaluated on a five-point Likert scale: "1 = Strongly disagree", "2 = Disagree", "3 = Undecided", "4 = Agree" and "5 = Strongly agree". The total score to be obtained from the BET subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are considered positive attitudes, and those <58 are considered negative attitudes. The total score to be obtained from the BEK subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are called good participation, and those with <58 are called poor participation.
Edinburgh Postpartum Depression Scale for Men
Time frame: 30 days after birth
It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 9/10, and men whose total scale score is higher than the cut-off point are considered to be in the risk group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- 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.
Ayla KANBUR principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USE OF MOBILE ULTRASOUND and ultrasound image taken from the internet in people with Ultrasonography Prenatal, run by Ataturk 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 16 inclusion and 13 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 17 May 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. Some participants in this study may receive a placebo. 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 merve Çakıl (+905310854245, mervecakil92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (For Women) (time frame: 30 days after birth). The study lists 8 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 17 May 2024.