ClinicalTrials.gg
CompletedNCT07773207Updated Aug 19, 2026

Midwife-Led Home-Based Postpartum Follow-up Program

An interventional study of Midwife-Led Home-Based Postpartum Follow-up Program and Routine Postpartum Care in Postpartum Period and Breast Feeding, sponsored by Serap Öner. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Serap Öner · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

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.

Enrollment
83rd of 252
98 · median 80
Started
2026
with 32 others
No phase
251 of 274
65 open now
Registered
264th of 274
by date

Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 83rd largest by enrollment of the 252 interventional ones that give a count, is one of 33 that started in 2026, is one of 251 with no phase, and was the 264th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

68 of the 274 studies in Breast Feeding with a site in Turkey are open now. Recruiting first, the newest first:

63 more — sign in →

All 68 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With 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 randomized controlled trial evaluated whether a structured, midwife-led home-based postpartum follow-up program could improve breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment among postpartum women. A total of 98 women were randomly assigned in a 1:1 ratio to either the intervention group or the control group. In addition to routine postpartum care, women in the intervention group received an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. Women in the control group received routine postpartum care. Breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment were assessed at baseline and at six weeks postpartum.

Read the detailed description

This study was designed as a parallel-group randomized controlled trial conducted among postpartum women at Elazig Fethi Sekin City Hospital in Türkiye. Participants were enrolled during the first 48 hours after birth and randomly allocated in a 1:1 ratio to an intervention group or a control group. Randomization was stratified according to mode of birth, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes.

Women assigned to the intervention group received a structured, midwife-led postpartum follow-up program in addition to routine care. The program included an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. The pre-discharge session addressed breastfeeding techniques, positioning and attachment, management of common breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and available sources of support. During the home visit, breastfeeding practices and postpartum needs were assessed, individualized counselling was provided, and identified problems were addressed. Telephone follow-up was used to reinforce previous education, assess ongoing concerns, and provide additional counselling when needed.

Women assigned to the control group received the routine postpartum care and discharge education provided by the hospital. They did not receive the structured home visit or telephone follow-up program during the study period.

The principal outcome was breastfeeding self-efficacy. Secondary outcomes included postpartum sleep quality and maternal attachment. Outcomes were assessed at baseline during the first 48 hours postpartum and again at six weeks postpartum using validated self-report instruments.

03

Conditions studied

  • Postpartum Period
  • Breast Feeding

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Keywords

  • Breastfeeding Self-Efficacy
  • Postpartum Sleep Quality
  • Maternal Attachment
  • Midwifery Care
  • Home Visits
  • Postpartum Follow-Up
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

  • Aged 18 years or older Delivered a singleton live-born infant at term (37 weeks of gestation or later) Intended to breastfeed Able to communicate in Turkish Provided written Both the mother and infant were medically stable and eligible for discharge following routine postpartum care

Exclusion criteria

Exclusion Criteria:

  • A maternal or infant medical condition contraindicating breastfeeding A severe maternal or infant complication requiring prolonged hospitalization or intensive care A diagnosed maternal psychiatric disorder that could interfere with participation Inability to participate in the scheduled follow-up procedures
Terms in these criteria, in plain language(1)

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Structured Midwife-Led Postpartum Follow-up Program

    Participants received routine postpartum care plus a structured, midwife-led follow-up program consisting of an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week.

    Behavioral: Midwife-Led Home-Based Postpartum Follow-up Program · Behavioral: Routine Postpartum Care

  • Active comparator
    Routine Postpartum Care

    Participants received the routine postpartum care and discharge education provided by the hospital. They did not receive the structured home visit or telephone follow-up program during the study period.

    Behavioral: Routine Postpartum Care

Interventions

  • BehavioralMidwife-Led Home-Based Postpartum Follow-up Program

    The program included a 15-minute individual education session before hospital discharge, a home visit of approximately 30 minutes during the second postpartum week, and telephone follow-up during the fourth postpartum week. The program addressed breastfeeding technique, positioning and attachment, management of breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and individualized problem-solving.

  • BehavioralRoutine Postpartum Care

    Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.

06

What researchers measure

Primary outcomes

  1. Change in Breastfeeding Self-Efficacy Scale Score

    Breastfeeding self-efficacy was assessed using the 33-item Breastfeeding Self-Efficacy Scale. Each item is scored from 1 to 5, producing a total score ranging from 33 to 165. Higher scores indicate greater breastfeeding self-efficacy. Change from baseline to six weeks postpartum was evaluated.

    Time frame: Baseline (within 48 hours postpartum) and six weeks postpartum

Secondary outcomes

  1. Change in Postpartum Sleep Quality Scale Score

    Postpartum sleep quality was assessed using the 14-item Postpartum Sleep Quality Scale. The total score ranges from 0 to 56, with higher scores indicating poorer postpartum sleep quality. Change from baseline to six weeks postpartum was evaluated.

    Time frame: Baseline (within 48 hours postpartum) and six weeks postpartum

  2. Change in Maternal Attachment Inventory Score

    Maternal attachment was assessed using the 26-item Maternal Attachment Inventory. Each item is scored from 1 to 4, producing a total score ranging from 26 to 104. Higher scores indicate stronger maternal attachment. Change from baseline to six weeks postpartum was evaluated.

    Time frame: Baseline (within 48 hours postpartum) and six weeks postpartum

  3. Exclusive Breastfeeding Status

    Exclusive breastfeeding status was assessed based on infant feeding during the preceding 24 hours. Infants receiving only breast milk, with no other food or liquid except medicines, vitamins, or minerals, were classified as exclusively breastfed. The outcome was recorded as yes or no.

    Time frame: Six weeks postpartum

07

Study locations

1 site
  • Elazig Fethi Sekin City Hospital
    Elazig, Turkey, Elâzığ 23280, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the findings reported in this article will be available from the corresponding author upon reasonable request. Data will be shared subject to ethical and confidentiality considerations.

Time frame: Beginning after publication of the study results, with no predetermined end date.

Access criteria: Researchers who submit a methodologically sound proposal may request access by contacting the corresponding author. Requests will be evaluated in accordance with participant confidentiality and the conditions of the ethics approval.

No publications or documents are linked to this record.

09

Timeline

Tracking 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

Ran from Feb 2026 to primary completion in Jul 2026, 5 months.

Of 503 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 5 months is below that.

Counting every sponsor, half of 511 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 14, 2026
First posted
Aug 19, 2026
StartActual
Feb 12, 2026
Primary completionActual
Jul 28, 2026
CompletionActual
Jul 28, 2026
Last update
Aug 19, 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.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07773207
Lead sponsor
Serap Öner
Collaborators
Firat University Scientific Research Projects Coordination Unit
Responsible party
Serap Öner (Assistant Professor, Firat University) — Sponsor-investigator
First posted
Aug 19, 2026
Start date
Feb 12, 2026
Primary completion
Jul 28, 2026
Completion
Jul 28, 2026
Last update
Aug 19, 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 completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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