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RecruitingNCT07292649Updated Apr 29, 2026

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

An observational study in Postpartum Depression (PPD), Labor Analgesia and Expectations, sponsored by University of Padova. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,640
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Postpartum Depression (PPD)
  • Labor Analgesia
  • Expectations

Keywords

  • postpartum depression
  • labor analgesia
  • epidural
  • expectations
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anesthetics
  • Language barrier
  • Contraindications to labor analgesia
  • Delivery by Cesarean section
  • Known history of psychiatric disorders (including major depression)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,640 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · 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).

    Procedure: Epidural analgesia · Procedure: Spinal analgesia for labour pain · Other: No neuraxial analgesia

Interventions

  • ProcedureEpidural analgesia

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

  • ProcedureSpinal analgesia for labour pain

    Single-shot spinal analgesia

  • OtherNo neuraxial analgesia

    Patients did not received spinal or epidural labour analgesia

05

What researchers measure

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.

    Time frame: 6 months since labour

Secondary outcomes

  1. 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.

    Time frame: from 24 to 48 hours since labour

  2. 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

    Time frame: six months since labour

  3. 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").

    Time frame: At delivery/birth

06

Study locations

1 of 1 sites recruiting
  • University Hospital of Padova
    Padova, Veneto 35127, Italy
    • Alessandro De Cassai, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07292649
Lead sponsor
University of Padova
Responsible party
Alessandro De Cassai (Principal Investigator, University of Padova) — Principal investigator
First posted
Dec 18, 2025
Start date
Jan 8, 2026
Primary completion
Jan 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Apr 29, 2026

Study contacts

Fabrizia Calabrese, MD
Contact
fabrizia.calabrese@aopd.veneto.it
+39 0498213090
Giulia Faccioli, MD
Contact
giuliafdg@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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