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NCT Number: NCT07292649

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.

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Key information

Conditions

Postpartum Depression (PPD) Depression, Postpartum Depressive Disorder Expectations Female Urogenital Diseases and Pregnancy Complications Labor Analgesia Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Padova

Padova, Veneto, 35127, Italy

Location status: Recruiting

Location contact

Alessandro De Cassai, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epidural Analgesia

Procedure

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

Spinal analgesia for labour pain

Procedure

Single-shot spinal analgesia

No neuraxial analgesia

Other

Patients did not received spinal or epidural labour analgesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. Early depressive symptoms

    Time frame: from 24 to 48 hours 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.

  2. Effect of Analgesia Within Expectations-Unmet Group

    Time frame: six months since labour

    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

  3. Pain Intensity and Maternal Expectations

    Time frame: At delivery/birth

    To assess the association between intrapartum pain intensity (measured by Visual Analog Scale, VAS) and group allocation ("Expectations met" vs "Expectations unmet").

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrizia Calabrese, MD

CONTACT

[email protected]

+39 0498213090

Giulia Faccioli, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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