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Completed

NCT Number: NCT04565730

Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Grup I= General anesthesia group

Other

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.

Grup II= Spinal anesthesia group

Other

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.

Primary outcomes

  1. Development of postnatal depression

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Aug 14, 2023

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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