Midwife-Led Digital Follow-Up After Cesarean Section (MID-CS)

April 13, 2026 updated by: Tuba Enise BENLI, Inonu University

The Effect of a Midwife-Led Digital Follow-Up Program on Postpartum Depression, Perceived Social Support, and Breastfeeding Self-Efficacy in Women After Cesarean Section: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section.

Participants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care.

Data will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools.

The study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 will be conducted as a randomized controlled trial to evaluate the effectiveness of a structured midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section.

The postpartum period is a critical phase for maternal adaptation, during which women may experience psychological challenges such as depression, as well as difficulties related to breastfeeding and perceived social support. Women who deliver by cesarean section may be particularly vulnerable due to physical recovery, delayed maternal-infant interaction, and increased dependency on external support.

Eligible participants will be recruited from a university hospital and will be randomly assigned to either an intervention group or a control group. Randomization will be performed using a computer-generated sequence to ensure allocation concealment.

Participants in the intervention group will receive a structured face-to-face education session provided by a midwife on the first postpartum day. This session will include information on breastfeeding techniques, management of common breastfeeding problems, emotional adaptation to motherhood, and the importance of social support.

Following the initial education, participants in the intervention group will be enrolled in a 4-week digital follow-up program. This program will include weekly educational messages, individualized counseling, and continuous support delivered via mobile communication platforms. Participants will be able to ask questions and receive guidance from the midwife throughout the follow-up period.

Participants in the control group will receive routine postpartum care without any additional structured education or digital follow-up support.

The primary outcomes of the study will include postpartum depression, perceived social support, and breastfeeding self-efficacy. These outcomes will be measured using validated instruments, including the Edinburgh Postnatal Depression Scale (EPDS), the Multidimensional Scale of Perceived Social Support (MSPSS), and the Breastfeeding Self-Efficacy Scale (BSES).

Data will be collected at three time points: baseline (postpartum day 1), at 1 week postpartum, and at 4 weeks postpartum.

This study will aim to contribute to evidence-based postpartum care by providing insights into the effectiveness of accessible, scalable, and midwife-led digital interventions in improving maternal psychological well-being and breastfeeding-related outcomes.

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 (Estimated)

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.
104

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged between 18 and 45 years
  • Women who have undergone cesarean section
  • Within the first 24 hours postpartum
  • Able to communicate in Turkish
  • Having a healthy singleton newborn
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • History of psychiatric disorders
  • Presence of severe maternal complications
  • Newborn requiring intensive care unit admission
  • Women with communication difficulties
  • Participation in another intervention study

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: Treatment
  • 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: Intervention Group
Participants will receive a midwife-led face-to-face education session and a 4-week digital follow-up program.
Behavioral: Midwife-Led Digital Follow-Up Program
Participants will receive a structured face-to-face education session on the first postpartum day followed by a 4-week digital follow-up program including weekly educational messages, individualized counseling, and continuous support via mobile communication platforms.
No Intervention: Control Group
Participants will receive routine postpartum care without additional structured support.

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
Postpartum Depression
Time Frame: Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Postpartum depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report scale with total scores ranging from 0 to 30. Higher scores will indicate more severe depressive symptoms.
Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Perceived Social Support
Time Frame: Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Perceived social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item scale with total scores ranging from 12 to 84. Higher scores will indicate greater perceived social support.
Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Breastfeeding Self-Efficacy
Time Frame: Baseline, 1 week, and 4 weeks postpartum
Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale (BSES), a 33-item scale with total scores ranging from 33 to 165. Higher scores will indicate higher breastfeeding self-efficacy.
Baseline, 1 week, and 4 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.
Inonu University

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.
Kahramanmaras Sutcu Imam University

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 (Estimated)

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.
June 1, 2026

Primary Completion (Estimated)

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.
September 1, 2026

Study Completion (Estimated)

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.
October 1, 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).
April 5, 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.
April 5, 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.
April 13, 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.
April 16, 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.
April 13, 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.
April 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.
  • GU-POST-CS-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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