Clinical trial NCT04565730: Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery
Official title: The Effect of Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Anesthesia
Postnatal depression
Cesarean delivery
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two models for this study. The first group is general anesthesia group. The second one is spinal anesthesia group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of postnatal depression
timeFrame: Change from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bagcilar
Study officials:
References:
citation: Munro A, MacCormick H, Sabharwal A, George RB. Pharmacologic labour analgesia and its relationship to postpartum psychiatric disorders: a scoping review. Can J Anaesth. 2020 May;67(5):588-604. doi: 10.1007/s12630-020-01587-7. Epub 2020 Feb 4.
citation: Kaya L, Cigdem Z. The relationship between mode of delivery and postpartum depression. J Educ Health Promot. 2019 Jan 29;8:5. doi: 10.4103/jehp.jehp_97_18. eCollection 2019.
citation: Chan CL, Tan CW, Chan JJI, Sultana R, Chua TE, Chen HY, Sia ATH, Sng BL. Factors Associated with the Development of Postnatal Depression After Cesarean Delivery: A Prospective Study. Neuropsychiatr Dis Treat. 2020 Mar 12;16:715-727. doi: 10.2147/NDT.S241984. eCollection 2020.
citation: Zanardo V, Giliberti L, Volpe F, Parotto M, de Luca F, Straface G. Cohort study of the depression, anxiety, and anhedonia components of the Edinburgh Postnatal Depression Scale after delivery. Int J Gynaecol Obstet. 2017 Jun;137(3):277-281. doi: 10.1002/ijgo.12138. Epub 2017 Mar 22.
citation: Yu HY, Wang SY, Quan CX, Fang C, Luo SC, Li DY, Zhen SS, Ma JH, Duan KM. Dexmedetomidine Alleviates Postpartum Depressive Symptoms following Cesarean Section in Chinese Women: A Randomized Placebo-Controlled Study. Pharmacotherapy. 2019 Oct;39(10):994-1004. doi: 10.1002/phar.2320. Epub 2019 Sep 15.