Postpartum DepressionMID-CSNCT07523932
Midwife-Led Digital Follow-Up After Cesarean Section
A study testing Midwife-Led Digital Follow-Up Program in people with Postpartum Depression and Breastfeeding, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression, Breastfeeding, Postpartum Period
- What is being tested?
- Midwife-Led Digital Follow-Up Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of psychiatric disorders
- Presence of severe maternal complications
- Newborn requiring intensive care unit admission
- Women with communication difficulties
- Participation in another intervention study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emel Güçlü Cihan contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Giresun University
Giresun, 28200
Tuba Benli, enise.benli@giresun.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Postpartum Depression, Breastfeeding, Postpartum Period
- Being tested
- Midwife-Led Digital Follow-Up Program
- Keywords
- Cesarean Section, Midwife-Led Intervention, Digital Follow-Up, Breastfeeding Self-Efficacy, Social Support, Postpartum Care
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-Led Digital Follow-Up ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a midwife-led face-to-face education session and a 4-week digital follow-up program. Receives: Behavioral: Midwife-Led Digital Follow-Up Program |
| Control Group | No intervention | Participants will receive routine postpartum care without additional structured support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression
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.
Measured: Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Perceived Social Support
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.
Measured: Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum
Breastfeeding Self-Efficacy
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.
Measured: Baseline, 1 week, and 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving a midwife-led digital follow-up program or a control group receiving routine postpartum care.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Principal investigator, Tuba Enise BENLI, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523932
- Sponsor's protocol ID
- GU-POST-CS-2026-01
- Acronym
- MID-CS
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07523932
- Acronym / sponsor ID
- MID-CS / GU-POST-CS-2026-01
- Conditions
- Postpartum Depression, Breastfeeding, Postpartum Period
- Keywords
- Cesarean Section, Midwife-Led Intervention, Digital Follow-Up, Breastfeeding Self-Efficacy, Social Support, Postpartum Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving a midwife-led digital follow-up program or a control group receiving routine postpartum care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Midwife-Led Digital Follow-Up ProgramParticipants will receive a midwife-led face-to-face education session and a 4-week digital follow-up program. |
| Control Group | No intervention | –Participants will receive routine postpartum care without additional structured support. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- History of psychiatric disorders
- Presence of severe maternal complications
- Newborn requiring intensive care unit admission
- Women with communication difficulties
- Participation in another intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midwife-Led Digital Follow-Up ProgramParticipants 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emel Güçlü Cihan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwife-Led Digital Follow-Up Program in people with Postpartum Depression and Breastfeeding, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba E Benli (+90 552 456 58 28, enise.benli@giresun.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression (time frame: Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.