Midwife-Led Home-Based Postpartum Follow-up Program

August 14, 2026 updated by: Serap Öner

Effectiveness of a Midwife-Led Home-Based Postpartum Follow-up Program on Breastfeeding Self-Efficacy, Sleep Quality, and Maternal Attachment: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 informed consent Both the mother and infant were medically stable and eligible for discharge following routine postpartum care

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Behavioral: Routine Postpartum Care
Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.
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
Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Breastfeeding Self-Efficacy Scale Score
Time Frame: Baseline (within 48 hours postpartum) and six weeks postpartum
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.
Baseline (within 48 hours postpartum) and six weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Postpartum Sleep Quality Scale Score
Time Frame: Baseline (within 48 hours postpartum) and six weeks postpartum
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.
Baseline (within 48 hours postpartum) and six weeks postpartum
Change in Maternal Attachment Inventory Score
Time Frame: Baseline (within 48 hours postpartum) and six weeks postpartum
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.
Baseline (within 48 hours postpartum) and six weeks postpartum
Exclusive Breastfeeding Status
Time Frame: Six weeks postpartum
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.
Six weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Serap Öner

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Firat University Scientific Research Projects Coordination Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYO.26.04 (Other Grant/Funding Number: Fırat University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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