BreastfeedingNCT05484076
The Effect of Lactation Counseling on Breastfeeding Behaviors of Women
A study testing breastfeeding counseling in people with Breastfeeding and Mothers, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Mothers
- What is being tested?
- breastfeeding counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2022to 6 Jun 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Not having received breastfeeding counseling before
- Being her first pregnancy
- Those who have a communication device that can use and download Teknolojik-Online systems (Smartphone, message, Google forms, zoom, whatsaap)
- Not having a vision-hearing problem
- Ability to read and write
Show all 10Show fewer
- Last trimester (34 and above gestational weeks)
- Single pregnancy
- Giving birth at term (38-40 weeks)
- The newborn does not have health problems that require hospitalization
Who cannot join
- Maternal (mastectomy, breast-milk infection and drug use, psychiatric diseases, etc.) preventing breastfeeding,
- Fetal (cleft palate, chromosomal anomalies, neurological diseases that may adversely affect breastfeeding, etc.)
- Unwillingness to continue research
- Having situations that require separation of mother and baby in the postpartum period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lactation Counseling on Breastfeeding Behaviors of Women: A Randomized Controlled Longitudinal Study
Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the article has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".
Read the detailed description
Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the project has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. It is basically a human right that every baby has the potential for a healthy future by being fed with breast milk. In particular, the disruptions experienced in health services during the pandemic process have also significantly affected maternal and child health services. In this respect, another unique value is that it is a longitudinal study that includes innovative methods to be taken at the national level to quickly compensate for the lost momentum in breastfeeding during the pandemic process. Face-to-face counseling and training will start during pregnancy, and then continue as telehealth services. Continuity of counseling will increase the mother's compliance with breastfeeding. Behavior change, which will be developed individually, will also positively affect mother-infant harmony and family-spouse harmony, thus supporting the creation of a healthy development environment. Another unique value of the study is that it will provide data on the comparison of innovative education methods with traditional education methods. Thus the findings obtained will help to improve, regulate or build capacity of future initiatives.
The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".
the scope of the widespread effect of our research; The training booklet prepared with the expert opinion for the training process will be brought to the field.
- Conditions
- Breastfeeding, Mothers
- Being tested
- breastfeeding counseling
- Keywords
- baby, breastfeeding, counseling, mother, telehealth
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding counselingOther
A breastfeeding booklet will be created by the researchers by taking expert opinion. This booklet will explain everything about breastfeeding in five sessions.
At 34-38 weeks of pregnancy, the first interviews will be done face-to-face at the hospital. The second interview will be made face-to-face or online, depending on the conditions, in the first 1-5 days after the birth. Subsequent interviews (postpartum 1-4 weeks, postpartum 5-12 weeks, postpartum 13-24 weeks) will be held online. The scales used in the research will be applied twice, before and after the training.
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding counseling | Experimental | Pregnant women will be given breastfeeding counseling, which will take place in a total of five sessions at specified intervals. Receives: Other: breastfeeding counseling |
| control group | No intervention | No training will be given to the control group. They will be asked to fill in the questionnaires included in our study at specified intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal Pregnant Information Form
This form, which was prepared by the researchers in line with the literature, consists of 11 questions containing the sociodemographic characteristics of pregnant women and pregnancy information.
Measured: 34-38 weeks of pregnancy
Postnatal Mother Information Form
this form, which was prepared in line with the literature review, consists of 18 questions that include information on mothers regarding the postpartum period, breastfeeding and baby.
Measured: postpartum 1-5 day
The Infant Breastfeeding Assesment Tool
The scale is a measurement tool developed to determine temporary feeding difficulties in the first 4 to 5 days in healthy and term babies. The scale consists of six questions and the evaluation is made by the mothers. Scoring is done on the basis of the mothers' answers to the questions. Each question is evaluated between 0-3 points (min:0, max:12). Getting a high score from the scale means that there is better. If the baby carries all the effective feeding behaviors, the grand total is 12 points. The score range for effectively fed infants is 10-12 points. The score range for babies who breastfeed quite successfully when encouraged is 7-9 points, and feeding is considered moderately effective. Babies who do not start feeding with stimuli, do not seek or breastfeed for short periods are evaluated in the range of 0-6 points. With this tool, maternal satisfaction and comfort during breastfeeding can also be evaluated.
Measured: postpartum first 6 months
Breastfeeding Motivation Scale
For multiparous mothers, it was determined by explanatory factor analysis that it consisted of 24 items and six sub-factors. According to the calculated Cronbach's alpha value, the Breastfeeding Motivation Scale is a very reliable scale for primiparous (cronbach's alpha: 0.887) and multiparous (cronbach's alpha: 0.914) mothers. The scale consists of 24 items and 5 sub-dimensions. The scale items are in 4-point Likert type, and each item is scored between 1-4 (min:24, max:96).The score of the sub-dimensions is calculated by taking the total score of the scale and the average of the sub-dimension scores of the scale. As the score obtained from the scale sub-dimension increases, it is interpreted as an increase in the motivation representing that sub-dimension. As the score obtained from the scale sub-dimension increases, it is interpreted as an increase in the motivation representing that sub-dimension.
Measured: postpartum first 6 months
Iowa Infant Nutrition Attitude Scale
The scale was developed in order to evaluate women's attitudes towards breastfeeding and to evaluate the duration of breastfeeding together with the choice of baby feeding method. The scale consists of 17 questions and the answers range from 1 (strongly disagree) to 5 (strongly agree). While 9 questions in the scale support breastfeeding, 8 items contain a supportive approach to formula feeding. The total score that can be obtained from the scale is between min: 17 and max: 85.
Total scale scores can be further categorized into groups:
- positive to breastfeeding (scale score 70-85),
- neutral (IIFAS score 49-69), and
- positive to formula feeding (scale score 17-48).
Measured: postpartum first 6 months
Mother-To-İnfant Bonding Scale
In 2005, Taylor et al. The scale developed by Karakulak and Alparslan was adapted to Turkish. The scale, which allows the mother to describe her feelings towards her baby with a single word, can be applied from the first day after birth. It reveals the relationship between the bond established and the mother's first period mood. The scale is in a 4-point Likert format, consisting of 8 items. The answers consisting of four options are scored between 0-3. The scale min:0, max: 24 score. In the evaluation, the 1st, 4th, and 6th items are positive emotion expressions and are scored as 0,1,2,3; 2.,3.,5.,7. Items 8 and 8 are negative emotional expressions and are scored as 3,2,1,0 and reversely. It has been reported that the inter-rater reliability of the scale is 0.71 and the Cronbach's Alpha is 0.66. High scale scores are interpreted as an increase in mother-infant attachment.
Measured: postpartum first 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start29 Oct 2022
- Primary completion26 Jan 2024
- Study completion6 Jun 2024
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 BreastfeedingStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Sonmez, Gaziantep Islam Science and Technology University
- Investigators
- tuğçe sönmez, PhD, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484076
- Sponsor's protocol ID
- 200720asel
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2022
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sonmez T, Surucu SG, Vurgec BA. Effects of hybrid breastfeeding counseling on women's breastfeeding behaviors: a randomized controlled longitudinal study. BMC Pregnancy Childbirth. 2025 Jun 7;25(1):663. doi: 10.1186/s12884-025-07781-z.
PubMed 40483454
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactation Counseling on Breastfeeding Behaviors of Women: A Randomized Controlled Longitudinal Study
- ClinicalTrials.gov ID
- NCT05484076
- Acronym / sponsor ID
- 200720asel
- Conditions
- Breastfeeding, Mothers
- Keywords
- baby, breastfeeding, counseling, mother, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 2 Aug 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.
Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the article has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".
Detailed description
Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the project has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. It is basically a human right that every baby has the potential for a healthy future by being fed with breast milk. In particular, the disruptions experienced in health services during the pandemic process have also significantly affected maternal and child health services. In this respect, another unique value is that it is a longitudinal study that includes innovative methods to be taken at the national level to quickly compensate for the lost momentum in breastfeeding during the pandemic process. Face-to-face counseling and training will start during pregnancy, and then continue as telehealth services. Continuity of counseling will increase the mother's compliance with breastfeeding. Behavior change, which will be developed individually, will also positively affect mother-infant harmony and family-spouse harmony, thus supporting the creation of a healthy development environment. Another unique value of the study is that it will provide data on the comparison of innovative education methods with traditional education methods. Thus the findings obtained will help to improve, regulate or build capacity of future initiatives.
The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".
the scope of the widespread effect of our research; The training booklet prepared with the expert opinion for the training process will be brought to the field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breastfeeding counseling | Experimental | Other: breastfeeding counselingPregnant women will be given breastfeeding counseling, which will take place in a total of five sessions at specified intervals. |
| control group | No intervention | –No training will be given to the control group. They will be asked to fill in the questionnaires included in our study at specified intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being over 18 years old
- Not having received breastfeeding counseling before
- Being her first pregnancy
- Those who have a communication device that can use and download Teknolojik-Online systems (Smartphone, message, Google forms, zoom, whatsaap)
- Not having a vision-hearing problem
Key exclusion criteria (4 listed)
- Maternal (mastectomy, breast-milk infection and drug use, psychiatric diseases, etc.) preventing breastfeeding,
- Fetal (cleft palate, chromosomal anomalies, neurological diseases that may adversely affect breastfeeding, etc.)
- Unwillingness to continue research
- Having situations that require separation of mother and baby in the postpartum period
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 |
|---|---|---|
| breastfeeding counselingA breastfeeding booklet will be created by the researchers by taking expert opinion. This booklet will explain everything about breastfeeding in five sessions. At 34-38 weeks of pregnancy, the first interviews will be done face-to-face at the hospital. The second interview will be made face-to-face or online, depending on the conditions, in the first 1-5 days after the birth. Subsequent interviews (postpartum 1-4 weeks, postpartum 5-12 weeks, postpartum 13-24 weeks) will be held online. The scales used in the research will be applied twice, before and after the training. | Other | breastfeeding counseling |
Primary outcome
Antenatal Pregnant Information Form
Time frame: 34-38 weeks of pregnancy
This form, which was prepared by the researchers in line with the literature, consists of 11 questions containing the sociodemographic characteristics of pregnant women and pregnancy information.
Postnatal Mother Information Form
Time frame: postpartum 1-5 day
this form, which was prepared in line with the literature review, consists of 18 questions that include information on mothers regarding the postpartum period, breastfeeding and baby.
The Infant Breastfeeding Assesment Tool
Time frame: postpartum first 6 months
The scale is a measurement tool developed to determine temporary feeding difficulties in the first 4 to 5 days in healthy and term babies. The scale consists of six questions and the evaluation is made by the mothers. Scoring is done on the basis of the mothers' answers to the questions. Each question is evaluated between 0-3 points (min:0, max:12). Getting a high score from the scale means that there is better. If the baby carries all the effective feeding behaviors, the grand total is 12 points. The score range for effectively fed infants is 10-12 points. The score range for babies who breastfeed quite successfully when encouraged is 7-9 points, and feeding is considered moderately effective. Babies who do not start feeding with stimuli, do not seek or breastfeed for short periods are evaluated in the range of 0-6 points. With this tool, maternal satisfaction and comfort during breastfeeding can also be evaluated.
Breastfeeding Motivation Scale
Time frame: postpartum first 6 months
For multiparous mothers, it was determined by explanatory factor analysis that it consisted of 24 items and six sub-factors. According to the calculated Cronbach's alpha value, the Breastfeeding Motivation Scale is a very reliable scale for primiparous (cronbach's alpha: 0.887) and multiparous (cronbach's alpha: 0.914) mothers. The scale consists of 24 items and 5 sub-dimensions. The scale items are in 4-point Likert type, and each item is scored between 1-4 (min:24, max:96).The score of the sub-dimensions is calculated by taking the total score of the scale and the average of the sub-dimension scores of the scale. As the score obtained from the scale sub-dimension increases, it is interpreted as an increase in the motivation representing that sub-dimension. As the score obtained from the scale sub-dimension increases, it is interpreted as an increase in the motivation representing that sub-dimension.
Iowa Infant Nutrition Attitude Scale
Time frame: postpartum first 6 months
The scale was developed in order to evaluate women's attitudes towards breastfeeding and to evaluate the duration of breastfeeding together with the choice of baby feeding method. The scale consists of 17 questions and the answers range from 1 (strongly disagree) to 5 (strongly agree). While 9 questions in the scale support breastfeeding, 8 items contain a supportive approach to formula feeding. The total score that can be obtained from the scale is between min: 17 and max: 85. Total scale scores can be further categorized into groups: 1. positive to breastfeeding (scale score 70-85), 2. neutral (IIFAS score 49-69), and 3. positive to formula feeding (scale score 17-48).
Mother-To-İnfant Bonding Scale
Time frame: postpartum first 6 months
In 2005, Taylor et al. The scale developed by Karakulak and Alparslan was adapted to Turkish. The scale, which allows the mother to describe her feelings towards her baby with a single word, can be applied from the first day after birth. It reveals the relationship between the bond established and the mother's first period mood. The scale is in a 4-point Likert format, consisting of 8 items. The answers consisting of four options are scored between 0-3. The scale min:0, max: 24 score. In the evaluation, the 1st, 4th, and 6th items are positive emotion expressions and are scored as 0,1,2,3; 2.,3.,5.,7. Items 8 and 8 are negative emotional expressions and are scored as 3,2,1,0 and reversely. It has been reported that the inter-rater reliability of the scale is 0.71 and the Cronbach's Alpha is 0.66. High scale scores are interpreted as an increase in mother-infant attachment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Derived from this study: PubMed 40483454Sonmez T, Surucu SG, Vurgec BA. Effects of hybrid breastfeeding counseling on women's breastfeeding behaviors: a randomized controlled longitudinal study. BMC Pregnancy Childbirth. 2025 Jun 7;25(1):663. doi: 10.1186/s12884-025-07781-z.
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
tuğçe sönmez, PhD principal investigator
Tarsus 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 breastfeeding counseling in people with Breastfeeding and Mothers, run by Gaziantep Islam Science and Technology 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antenatal Pregnant Information Form (time frame: 34-38 weeks of pregnancy). The study lists 6 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 NCT05484076, 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 10 Jun 2024.