Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational 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.

Study Overview

• Status: Recruiting
• Conditions: Labor Analgesia; Expectations; Postpartum Depression (PPD)
• Intervention / Treatment: Procedure: Epidural analgesia; Procedure: Spinal analgesia for labour pain; Other: No neuraxial analgesia

• Study Type: Observational
• Enrollment (Estimated): 3640

Contacts and Locations

• Study Contact: Name: Fabrizia Calabrese, MD; Phone Number: +39 0498213090; Email: fabrizia.calabrese@aopd.veneto.it
• Study Contact Backup: Name: Giulia Faccioli, MD; Email: giuliafdg@gmail.com

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • Recruiting
      • University Hospital of Padova
      • Contact: Alessandro De Cassai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 analgesia; Analgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor.; Procedure: Spinal analgesia for labour pain; Single-shot spinal analgesia; Other: No neuraxial analgesia; Patients did not received spinal or epidural labour 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 analgesia; Analgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor.; Procedure: Spinal analgesia for labour pain; Single-shot spinal analgesia; Other: No neuraxial analgesia; Patients did not received spinal or epidural labour analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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").	At delivery/birth

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: September 13, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: epidural; postpartum depression; labor analgesia; expectations
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Anesthesia and Analgesia; Analgesia; Analgesia, Epidural
• Other Study ID Numbers: 6311/AO/25; AOP 3794 (Other Identifier: University Hospital of Padua, Italy)

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