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Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

The Effect of Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery: a Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565730
Enrollment
200
Registered
2020-09-25
Start date
2020-10-27
Completion date
2023-08-10
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

Anesthesia, Postnatal depression, Cesarean delivery

Brief summary

Childbirth is one of the most painful experiences for a woman. Labor and period of pregnancy is associated with an increased risk of psychiatric disorders for a woman. The demands of pregnancy and childbirth make patients vulnerable to psychiatric disorders such as postpartum depression (PPD), anxiety, and stress disorders. Women with postpartum psychiatric disorders have high mortality rates. The most common postpartum psychiatric disorder is PPD. PPD occurs any time in pregnancy or in the first four weeks after delivery. It may lead to complications such as emotional lability in the mother. This situation may also effect the child.

Detailed description

Childbirth is one of the most painful experiences for a woman. Labor and period of pregnancy is associated with an increased risk of psychiatric disorders for a woman. The demands of pregnancy and childbirth make patients vulnerable to psychiatric disorders such as postpartum depression (PPD), anxiety, and stress disorders. Women with postpartum psychiatric disorders have high mortality rates. The most common postpartum psychiatric disorder is PPD. PPD occurs any time in pregnancy or in the first four weeks after delivery. It may lead to complications such as emotional lability in the mother. This situation may also effect the child. Postpartum depression (PD) has become the most frequent complication of childbirth. Its prevalence has been estimated as 10%-15% and its formation is affected by several factors such as lack of social support, previous history of depression, and personal vulnerability. There are several studies about PD in the literature, some discuss about the relation of pain and PD, some discuss about the relation of epidural anesthesia and PD. However, there is no study that compares different anesthesia methods (general anesthesia vs spinal anesthesia) on development of postnatal depression after cesarean delivery. The aim of this study is to compare the different anesthesia methods (general anesthesia vs spinal anesthesia) on development of postnatal depression after cesarean delivery. The secondary aim is to decrease the ratio of postnatal depression after cesarean delivery.

Interventions

OTHERGrup I= General anesthesia group

Preoperative and postoperative evaluation Pre-operative data will be collected 1 to 2 hrs before operation. Preoperative anxiety level will be assessed by the Hospital Anxiety and Depression Scale (HADS) and Amsterdam Preoperative Anxiety and Information Scale. Patients will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) on the morning of discharge, 1 months and 3 months days after delivery. An online survey will be conducted post-Cesarean delivery to investigate the primary outcome of PND using EPDS, and those will not complete the online survey received phone calls to conduct the follow-up surveys.

OTHERGrup II= Spinal anesthesia group

Preoperative and postoperative evaluation Pre-operative data will be collected 1 to 2 hrs before operation. Preoperative anxiety level will be assessed by the Hospital Anxiety and Depression Scale (HADS) and Amsterdam Preoperative Anxiety and Information Scale. Patients will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) on the morning of discharge, 1 months and 3 months days after delivery. An online survey will be conducted post-Cesarean delivery to investigate the primary outcome of PND using EPDS, and those will not complete the online survey received phone calls to conduct the follow-up surveys.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The anesthesiologist who performs postoperative pain evaluation will not know the group.

Intervention model description

There are two models for this study. The first group is general anesthesia group. The second one is spinal anesthesia group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Aged 21-50 years old * 36 gestational weeks or more, * American Society of Anesthesiologists' (ASA) I and II * Able to communicate

Exclusion criteria

* history of bipolar or psychotic disorder * suicidal state * Chronic pain syndrome * Intraoperative complication * drug and/or alcohol abuse * who did not want to participate * emergency cases * unable to communicate in Turkish

Design outcomes

Primary

MeasureTime frameDescription
Development of postnatal depressionChange from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.The aim of this study is to compare the different anesthesia methods (general anesthesia vs spinal anesthesia) on development of postnatal depression after cesarean delivery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026