NCT07292649

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,640

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Jun 2029

First Submitted

Initial submission to the registry

September 13, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

January 8, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

September 13, 2025

Last Update Submit

April 28, 2026

Conditions

Postpartum Depression (PPD)Labor AnalgesiaExpectations

Keywords

postpartum depressionlabor analgesiaepiduralexpectations

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months since labour

Secondary Outcomes (3)

  • Early depressive symptoms

    from 24 to 48 hours since labour

  • Effect of Analgesia Within Expectations-Unmet Group

    six months since labour

  • Pain Intensity and Maternal Expectations

    At delivery/birth

Study Arms (2)

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).

Procedure: Epidural analgesiaProcedure: Spinal analgesia for labour painOther: 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).

Procedure: Epidural analgesiaProcedure: Spinal analgesia for labour painOther: No neuraxial analgesia

Interventions

Epidural analgesiaPROCEDURE

Analgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor.

Expectations met (Intended = Received)Expectations unmet (Intended ≠ Received)
No neuraxial analgesiaOTHER

Patients did not received spinal or epidural labour analgesia

Expectations met (Intended = Received)Expectations unmet (Intended ≠ Received)
Spinal analgesia for labour painPROCEDURE

Single-shot spinal analgesia

Expectations met (Intended = Received)Expectations unmet (Intended ≠ Received)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients undergoing a spontaneous or induced vaginal delivery, regardless of whether they request epidural analgesia.

You may qualify if:

  • Signed informed consent
  • Planned vaginal delivery (spontaneous or induced)
  • Pregnancy
  • Age \> 18 years

You may not qualify if:

  • Allergy to local anesthetics
  • Language barrier
  • Contraindications to labor analgesia
  • Delivery by Cesarean section
  • Known history of psychiatric disorders (including major depression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padova

Padova, Veneto, 35127, Italy

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Central Study Contacts

Fabrizia Calabrese, MD

CONTACT

+39 0498213090fabrizia.calabrese@aopd.veneto.it

Giulia Faccioli, MD

CONTACT

giuliafdg@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2025

First Posted

December 18, 2025

Study Start

January 8, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)