Breastfeeding InitiationNCT07864753
EVALUATION OF TWO MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH
A study testing Midwife-Supported Modified Football Hold Group and Midwife-Supported Cradle Hold Group in people with Breastfeeding Initiation and Midwifery Support, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
This study is being conducted by Dr. Benay OĞUZ. This form has been prepared to inform you about the conditions and procedures of the study. Title of the Study: Evaluation of Two Different Midwife-Supported Breastfeeding Positions During the First Breastfeeding After Vaginal Birth: A Randomized Controlled Trial What… 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 Initiation, Midwifery Support, Breastfeeding Support
- What is being tested?
- Midwife-Supported Modified Football Hold Group and Midwife-Supported Cradle Hold Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Vaginal singleton birth at 37-42 weeks of gestation
- Healthy newborn with an Apgar score ≥7 at 5 minutes
- Mother and newborn clinically stable and eligible for breastfeeding
- First breastfeeding initiated in the study hospital
- Ability to communicate in Turkish
- Willingness to participate and provision of written informed consent
Who cannot join
- Cesarean birth
- Multiple pregnancy
- Preterm birth (<37 weeks) or post-term birth (>42 weeks)
- Newborn requiring admission to the neonatal intensive care unit
- Congenital anomalies or medical conditions affecting breastfeeding
- Maternal conditions contraindicating breastfeeding, such as severe postpartum complications or other medical contraindications
- Maternal or neonatal condition preventing the first breastfeeding session
- Refusal or withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Cigli Training and Research Hospital
İzmir, Balıkesir, 10050
About this study
Official title: EVALUATION OF TWO DIFFERENT MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH: A RANDOMIZED CONTROLLED TRIAL
This study is being conducted by Dr. Benay OĞUZ. This form has been prepared to inform you about the conditions and procedures of the study.
Title of the Study: Evaluation of Two Different Midwife-Supported Breastfeeding Positions During the First Breastfeeding After Vaginal Birth: A Randomized Controlled Trial
Read more
What Is the Purpose of the Study? The purpose of this study is to evaluate the effects of two different breastfeeding positions, applied with midwife support during the first breastfeeding after vaginal birth, on breastfeeding success. If you agree to participate in the study, you will be expected to allow the midwife to support you during breastfeeding. Your participation in this study will take approximately 20 minutes.
How Will We Use the Information Collected from You? Your participation in this study is entirely voluntary. You will not be asked to provide any information that could identify you or your institution. Your information will be kept strictly confidential and will be evaluated only by the researchers. The information obtained from the participants will be analyzed collectively and may be used in scientific publications. The data you provide will not be matched with any identifying information collected through the voluntary participation forms.
Approximately 80 postpartum women who voluntarily agree to participate are expected to be included in this study.
What You Should Know About Participation: This study does not involve any additional risks beyond those that may ordinarily be encountered in daily life. The intervention consists of midwife-supported breastfeeding positioning, which is part of routine postpartum care, and observational assessment of breastfeeding.
Midwife support during the first breastfeeding may contribute to improving maternal comfort and reducing breastfeeding difficulties in the early postpartum period by facilitating more effective positioning.
If you feel uncomfortable for any reason during your participation, you are free to withdraw from the study at any time. In such a case, it will be sufficient to inform the researcher verbally or by email that you wish to withdraw from the study. At the end of the study, any questions you may have regarding the research will be answered.
- Being tested
- Midwife-Supported Modified Football Hold Group, Midwife-Supported Cradle Hold Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-Supported Modified Football Hold GroupOther
Intervention Description
Participants randomized to the modified football hold group will receive standardized midwife-supported breastfeeding assistance during the first breastfeeding session after vaginal birth. The mother will be positioned in a comfortable supine position with appropriate pillow support as needed. The infant will be positioned nearly perpendicular to the mother's torso, with the feet directed toward the mother's shoulder and the head aligned with the breast. The attending midwife will support the infant's head to facilitate proper latch while stabilizing the infant's back and hips to promote effective breastfeeding. Continuous guidance on positioning and attachment will be provided throughout the first breastfeeding session.
Participants randomized to the cradle hold group will receive standardized midwife-supported breastfeeding assistance using the cradle hold during the first breastfeeding session after vaginal birth. The mother will be positioned in a semi-up
Midwife-Supported Cradle Hold GroupOther
Participants assigned to this arm will receive standardized midwife-supported breastfeeding using the cradle hold position during the first breastfeeding session after vaginal birth. Mothers will be positioned in a semi-upright or upright sitting position, while infants will be placed parallel to the mother's body with appropriate head, back, and hip support. The midwife will provide standardized guidance to ensure correct positioning and effective latch throughout the breastfeeding session. Outcomes will be assessed immediately after completion of the first breastfeeding session.
| Study group | Role | What they receive |
|---|---|---|
| Midwife-Supported Modified Football Hold Group | Experimental | Not described Receives: Other: Midwife-Supported Modified Football Hold Group |
| Midwife-Supported Cradle Hold Group | Active comparator | Not described Receives: Other: Midwife-Supported Cradle Hold Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Success
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool immediately after completion of the first breastfeeding session following vaginal birth. Total scores range from 0 to 10, with higher scores indicating better breastfeeding success.
Measured: Immediately after completion of the first breastfeeding session, within the first 1 hour after vaginal birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding InitiationStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benay Oğuz, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864753
- Sponsor's protocol ID
- 2923/2911/17.04.2026
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Oguz B, Bolsoy N. Evaluation of Two Midwife-Supported Breastfeeding Positions After Cesarean: A Pilot Randomized Controlled Study. Breastfeed Med. 2026 Apr;21(4):250-257. doi: 10.1177/15568253261415604. Epub 2026 Jan 21.
PubMed 41995054
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF TWO DIFFERENT MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07864753
- Acronym / sponsor ID
- 2923/2911/17.04.2026
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted by Dr. Benay OĞUZ. This form has been prepared to inform you about the conditions and procedures of the study.
Title of the Study: Evaluation of Two Different Midwife-Supported Breastfeeding Positions During the First Breastfeeding After Vaginal Birth: A Randomized Controlled Trial
What Is the Purpose of the Study? The purpose of this study is to evaluate the effects of two different breastfeeding positions, applied with midwife support during the first breastfeeding after vaginal birth, on breastfeeding success. If you agree to participate in the study, you will be expected to allow the midwife to support you during breastfeeding. Your participation in this study will take approximately 20 minutes.
How Will We Use the Information Collected from You? Your participation in this study is entirely voluntary. You will not be asked to provide any information that could identify you or your institution. Your information will be kept strictly confidential and will be evaluated only by the researchers. The information obtained from the participants will be analyzed collectively and may be used in scientific publications. The data you provide will not be matched with any identifying information collected through the voluntary participation forms.
Approximately 80 postpartum women who voluntarily agree to participate are expected to be included in this study.
What You Should Know About Participation: This study does not involve any additional risks beyond those that may ordinarily be encountered in daily life. The intervention consists of midwife-supported breastfeeding positioning, which is part of routine postpartum care, and observational assessment of breastfeeding.
Midwife support during the first breastfeeding may contribute to improving maternal comfort and reducing breastfeeding difficulties in the early postpartum period by facilitating more effective positioning.
If you feel uncomfortable for any reason during your participation, you are free to withdraw from the study at any time. In such a case, it will be sufficient to inform the researcher verbally or by email that you wish to withdraw from the study. At the end of the study, any questions you may have regarding the research will be answered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midwife-Supported Modified Football Hold Group | Experimental | Other: Midwife-Supported Modified Football Hold Group |
| Midwife-Supported Cradle Hold Group | Active comparator | Other: Midwife-Supported Cradle Hold Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 years or older
- Vaginal singleton birth at 37-42 weeks of gestation
- Healthy newborn with an Apgar score ≥7 at 5 minutes
- Mother and newborn clinically stable and eligible for breastfeeding
- First breastfeeding initiated in the study hospital
Key exclusion criteria (8 listed)
- Cesarean birth
- Multiple pregnancy
- Preterm birth (<37 weeks) or post-term birth (>42 weeks)
- Newborn requiring admission to the neonatal intensive care unit
- Congenital anomalies or medical conditions affecting breastfeeding
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 |
|---|---|---|
| Midwife-Supported Modified Football Hold GroupIntervention Description Participants randomized to the modified football hold group will receive standardized midwife-supported breastfeeding assistance during the first breastfeeding session after vaginal birth. The mother will be positioned in a comfortable supine position with appropriate pillow support as needed. The infant will be positioned nearly perpendicular to the mother's torso, with the feet directed toward the mother's shoulder and the head aligned with the breast. The attending midwife will support the infant's head to facilitate proper latch while stabilizing the infant's back and hips to promote effective breastfeeding. Continuous guidance on positioning and attachment will be provided throughout the first breastfeeding session. Participants randomized to the cradle hold group will receive standardized midwife-supported breastfeeding assistance using the cradle hold during the first breastfeeding session after vaginal birth. The mother will be positioned in a semi-up | Other | Midwife-Supported Modified Football Hold Group |
| Midwife-Supported Cradle Hold GroupParticipants assigned to this arm will receive standardized midwife-supported breastfeeding using the cradle hold position during the first breastfeeding session after vaginal birth. Mothers will be positioned in a semi-upright or upright sitting position, while infants will be placed parallel to the mother's body with appropriate head, back, and hip support. The midwife will provide standardized guidance to ensure correct positioning and effective latch throughout the breastfeeding session. Outcomes will be assessed immediately after completion of the first breastfeeding session. | Other | Midwife-Supported Cradle Hold Group |
Primary outcome
Breastfeeding Success
Time frame: Immediately after completion of the first breastfeeding session, within the first 1 hour after vaginal birth.
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool immediately after completion of the first breastfeeding session following vaginal birth. Total scores range from 0 to 10, with higher scores indicating better breastfeeding success.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 41995054Oguz B, Bolsoy N. Evaluation of Two Midwife-Supported Breastfeeding Positions After Cesarean: A Pilot Randomized Controlled Study. Breastfeed Med. 2026 Apr;21(4):250-257. doi: 10.1177/15568253261415604. Epub 2026 Jan 21.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwife-Supported Modified Football Hold Group and Midwife-Supported Cradle Hold Group in people with Breastfeeding Initiation and Midwifery Support, run by Balikesir 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 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Breastfeeding Success (time frame: Immediately after completion of the first breastfeeding session, within the first 1 hour after vaginal birth.). 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 NCT07864753, 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 8 Oct 2026.