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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

104

Phase

  • 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 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

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
Intervention / Treatment
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

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

Inonu University

Collaborators

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)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Postpartum Depression

Clinical Trials on Midwife-Led Digital Follow-Up Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe