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

NCT ID: NCT07292649

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postpartum Depression (PPD) Labor Analgesia Expectations

Keywords

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postpartum depression labor analgesia epidural expectations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Epidural analgesia

Intervention Type PROCEDURE

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

Spinal analgesia for labour pain

Intervention Type PROCEDURE

Single-shot spinal analgesia

No neuraxial analgesia

Intervention Type OTHER

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).

Epidural analgesia

Intervention Type PROCEDURE

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

Spinal analgesia for labour pain

Intervention Type PROCEDURE

Single-shot spinal analgesia

No neuraxial analgesia

Intervention Type OTHER

Patients did not received spinal or epidural labour analgesia

Interventions

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Epidural analgesia

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

Intervention Type PROCEDURE

Spinal analgesia for labour pain

Single-shot spinal analgesia

Intervention Type PROCEDURE

No neuraxial analgesia

Patients did not received spinal or epidural labour analgesia

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Alessandro De Cassai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Fabrizia Calabrese, MD

Role: CONTACT

Phone: +39 0498213090

Email: [email protected]

Giulia Faccioli, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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6311/AO/25

Identifier Type: -

Identifier Source: org_study_id

AOP 3794

Identifier Type: OTHER

Identifier Source: secondary_id