ClinicalTrials.gg
Active, not recruitingNCT07864753Updated Oct 8, 2026

EVALUATION OF TWO MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH

An interventional study of Midwife-Supported Modified Football Hold Group and Midwife-Supported Cradle Hold Group in Breastfeeding Initiation, Midwifery Support and Breastfeeding Support, sponsored by Balikesir University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Balikesir University · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 274 studies in Breast Feeding with a site in Turkey — 68 open to participants now, 77 under way, none of them phase 3. Breast Feeding · Turkey.

Planned enrollment
120th of 252
80 · median 80
Started
2026
with 32 others
No phase
251 of 274
65 open now
Primary completion
2026-12
later than 59 of 76 live
Registered
263rd of 274
by date

Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 120th largest by planned enrollment of the 252 interventional ones, is one of 33 that started in 2026, is one of 251 with no phase, reaches primary completion later than 59 of the 76 other live ones, and was the 263rd registered.

By phase

274 studies; the count open now beside each. This study's row is marked.

No phasethis study251 · 65 open
Observational22 · 3 open
Phase 41 · 0 open

By the year they started

First in 2011; this study’s year is marked. 33 started in 2026.

What they test

Size and results

Median enrollment 80 across the 252 interventional studies, 163 across the 22 observational. Of the 178 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 274 studies in Breast Feeding with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Breastfeeding Initiation
  • Midwifery Support
  • Breastfeeding Support

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Maternal or neonatal condition preventing the first breastfeeding session
  • Refusal or withdrawal of
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Midwife-Supported Modified Football Hold Group

    Other: Midwife-Supported Modified Football Hold Group

  • Active comparator
    Midwife-Supported Cradle Hold Group

    Other: Midwife-Supported Cradle Hold Group

Interventions

  • OtherMidwife-Supported Modified Football Hold Group

    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

  • OtherMidwife-Supported Cradle Hold Group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after completion of the first breastfeeding session, within the first 1 hour after vaginal birth.

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Statistical analysis plan, Clinical study report, Analytic code

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.

Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 6 months is below that.

Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Oct 8, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Jun 1, 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864753
Lead sponsor
Balikesir University
Responsible party
Benay Oğuz (Lecturer, PhD, Department of Midwifery, Balikesir University) — Principal investigator
First posted
Oct 8, 2026
Start date
Jun 1, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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