Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Padova
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Planned vaginal delivery (spontaneous or induced)
Pregnancy
Age > 18 years
Disqualifiers
Allergy to local anesthetics
Language barrier
Contraindications to labor analgesia
Delivery by Cesarean section
Trial population
The study population consists of patients undergoing a spontaneous or induced vaginal delivery, regardless of whether they request epidural analgesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Epidural analgesia
Procedure/SurgeryAnalgesia via epidural catheter using local anesthetic ± opioid, administered on patient request during labor.
Spinal analgesia for labour pain
Procedure/SurgerySingle-shot spinal analgesia
No neuraxial analgesia
Other interventionPatients did not received spinal or epidural labour analgesia
Treatment groups
3,640 Participants
are divided into 2 treatment groupsGroup A: Expectations met (Intended = Received)3 interventions
Group B: Expectations unmet (Intended ≠ Received)3 interventions
Trial outcomes
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 labourSecondary 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 labour2
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 labour3
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/birthSponsors and contacts
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Source ClinicalTrials.gov