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

NCT07292649 | Not Yet Recruiting

• 2 other identifiers: 6311/AO/25AOP 3794
• Study Type: observational
• Target: 3,640
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Depression (PPD); Labor Analgesia; Expectations

Keywords

postpartum depression; labor analgesia; epidural; expectations

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 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

Epidural analgesia PROCEDURE

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

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

Spinal analgesia for labour pain PROCEDURE

Single-shot spinal analgesia

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

No neuraxial analgesia OTHER

Patients did not received spinal or epidural labour analgesia

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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)

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Fabrizia Calabrese, MD

CONTACT

+39 0498213090; fabrizia.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 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share