Postpartum Depression (PPD)NCT07292649
Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational Study
An observational study of Postpartum Depression (PPD) and Labor Analgesia, run by University of Padova at 1 site in Italy.
Trial summary
Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD), Labor Analgesia, Expectations
- What is being tested?
- Epidural analgesia, Spinal analgesia for labour pain and No neuraxial analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 3,640 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2026to Jun 2029
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients undergoing a spontaneous or induced vaginal delivery, regardless of whether they request epidural analgesia.
Who may be able to join
- Signed informed consent
- Planned vaginal delivery (spontaneous or induced)
- Pregnancy
- Age > 18 years
Who cannot join
- Allergy to local anesthetics
- Language barrier
- Contraindications to labor analgesia
- Delivery by Cesarean section
- Known history of psychiatric disorders (including major depression)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Faccioli, MD contact
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Padova
Padova, Veneto, 35127
Alessandro De Cassai, MD
About this study
Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
- Conditions
- Postpartum Depression (PPD), Labor Analgesia, Expectations
- Being tested
- Epidural analgesia, Spinal analgesia for labour pain, No neuraxial analgesia
- Keywords
- postpartum depression, labor analgesia, epidural, expectations
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaProcedure or surgery
Analgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor.
Spinal analgesia for labour painProcedure or surgery
Single-shot spinal analgesia
No neuraxial analgesiaOther
Patients did not received spinal or epidural labour analgesia
| Study group | Role | What they receive |
|---|---|---|
| Expectations met (Intended = Received) | Participants whose prenatal intention regarding labor analgesia matched what they received (includes Intention Yes/Received Yes and Intention No/Received No). Receives: Procedure: Epidural analgesia; Procedure: Spinal analgesia for labour pain; Other: No neuraxial analgesia | |
| Expectations unmet (Intended ≠ Received) | Participants whose prenatal intention did not match the analgesia actually received (includes Intention Yes/Received No and Intention No/Received Yes). Receives: Procedure: Epidural analgesia; Procedure: Spinal analgesia for labour pain; Other: No neuraxial analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postpartum depression
To assess whether there is a statistically significant difference in the incidence of postpartum depression (PPD), defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 at 6 months postpartum, between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
Measured: 6 months since labour
Secondary outcomes (3)
Early depressive symptoms
To assess whether there is a statistically significant difference in the incidence of postpartum depression (PPD), defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 at 6 months postpartum, between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
Measured: from 24 to 48 hours since labour
Effect of Analgesia Within Expectations-Unmet Group
To compare the incidence of postpartum depression (EPDS ≥ 10 at 6 months) within the "Expectations unmet" group, stratified by actual receipt of neuraxial labor analgesia (epidural or spinal) versus no neuraxial analgesia
Measured: six months since labour
Pain Intensity and Maternal Expectations
To assess the association between intrapartum pain intensity (measured by Visual Analog Scale, VAS) and group allocation ("Expectations met" vs "Expectations unmet").
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start8 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292649
- Sponsor's protocol ID
- 6311/AO/25
- Other IDs
- AOP 3794
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2025
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational Study
- ClinicalTrials.gov ID
- NCT07292649
- Acronym / sponsor ID
- 6311/AO/25
- Conditions
- Postpartum Depression (PPD), Labor Analgesia, Expectations
- Keywords
- postpartum depression, labor analgesia, epidural, expectations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,640 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Dec 2025 (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.
Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectations met (Intended = Received) | – | Procedure: Epidural analgesia, Procedure: Spinal analgesia for labour pain, Other: No neuraxial analgesiaParticipants whose prenatal intention regarding labor analgesia matched what they received (includes Intention Yes/Received Yes and Intention No/Received No). |
| Expectations unmet (Intended ≠ Received) | – | Procedure: Epidural analgesia, Procedure: Spinal analgesia for labour pain, Other: No neuraxial analgesiaParticipants whose prenatal intention did not match the analgesia actually received (includes Intention Yes/Received No and Intention No/Received Yes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing a spontaneous or induced vaginal delivery, regardless of whether they request epidural analgesia.
Key inclusion criteria (4 listed)
- Signed informed consent
- Planned vaginal delivery (spontaneous or induced)
- Pregnancy
- Age > 18 years
Key exclusion criteria (5 listed)
- Allergy to local anesthetics
- Language barrier
- Contraindications to labor analgesia
- Delivery by Cesarean section
- Known history of psychiatric disorders (including major depression)
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 |
|---|---|---|
| Epidural analgesiaAnalgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor. | Procedure or surgery | Expectations met (Intended = Received), Expectations unmet (Intended ≠ Received) |
| Spinal analgesia for labour painSingle-shot spinal analgesia | Procedure or surgery | Expectations met (Intended = Received), Expectations unmet (Intended ≠ Received) |
| No neuraxial analgesiaPatients did not received spinal or epidural labour analgesia | Other | Expectations met (Intended = Received), Expectations unmet (Intended ≠ Received) |
Primary outcome
incidence of postpartum depression
Time frame: 6 months since labour
To assess whether there is a statistically significant difference in the incidence of postpartum depression (PPD), defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 at 6 months postpartum, between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.
3 secondary outcomes
Early depressive symptoms
Time frame: from 24 to 48 hours since labour
Effect of Analgesia Within Expectations-Unmet Group
Time frame: six months since labour
Pain Intensity and Maternal Expectations
Time frame: At delivery/birth
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Giulia Faccioli, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression (PPD) and Labor Analgesia, run by University of Padova at 1 site in Italy.
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 4 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 29 Apr 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 Italy. 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 Fabrizia Calabrese, MD (+39 0498213090, fabrizia.calabrese@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postpartum depression (time frame: 6 months since labour). 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 29 Apr 2026.