search
Back to results

Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

Primary Purpose

Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Grup I= General anesthesia group
Grup II= Spinal anesthesia group
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Anesthesia, Postnatal depression, Cesarean delivery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Grup I= General anesthesia group

Grup II= Spinal anesthesia group

Arm Description

After applying standard ASA monitoring; 2-2,5 mg/kg propofol, and 0,6 mg/kg rocuronium IV will be performed for general anesthesia induction, and then orotracheal intubation will be performed. The patients will be placed in the supine position. General anesthesia will be maintained with sevoflurane in the mixture of oxygen-fresh air. Controlled mechanical ventilation will be initiated with a tidal volume of 8-10 ml/kg at 12 breaths per minute (I:E ratio 1:2), a fresh gas flow rate of 2 L per min, end tidal CO2 value at 30-35 mmHg, and peak airway pressure of maximally 30 cm H2O. All patients will undergo cesarean delivery surgery with the same technique by the same surgical team.

A standardized spinal anesthesia will administrated to the patients. After skin disinfection, 25G needle will used for puncture at the level of L2-L3 or L3-L4. After observing the cerebrospinal fluid, 15 mg bupivacaine (marcain spinal heavy) will be administered into the subarachnoid space. The level of anesthesia below T6 will be controlled.

Outcomes

Primary Outcome Measures

Development of postnatal depression
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
August 9, 2023
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT04565730
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
Anesthesia, Postnatal depression, Cesarean delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is general anesthesia group. The second one is spinal anesthesia group
Masking
Outcomes Assessor
Masking Description
The anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup I= General anesthesia group
Arm Type
Active Comparator
Arm Description
After applying standard ASA monitoring; 2-2,5 mg/kg propofol, and 0,6 mg/kg rocuronium IV will be performed for general anesthesia induction, and then orotracheal intubation will be performed. The patients will be placed in the supine position. General anesthesia will be maintained with sevoflurane in the mixture of oxygen-fresh air. Controlled mechanical ventilation will be initiated with a tidal volume of 8-10 ml/kg at 12 breaths per minute (I:E ratio 1:2), a fresh gas flow rate of 2 L per min, end tidal CO2 value at 30-35 mmHg, and peak airway pressure of maximally 30 cm H2O. All patients will undergo cesarean delivery surgery with the same technique by the same surgical team.
Arm Title
Grup II= Spinal anesthesia group
Arm Type
Active Comparator
Arm Description
A standardized spinal anesthesia will administrated to the patients. After skin disinfection, 25G needle will used for puncture at the level of L2-L3 or L3-L4. After observing the cerebrospinal fluid, 15 mg bupivacaine (marcain spinal heavy) will be administered into the subarachnoid space. The level of anesthesia below T6 will be controlled.
Intervention Type
Other
Intervention Name(s)
Grup I= General anesthesia group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Grup II= Spinal anesthesia group
Intervention Description
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 Outcome Measure Information:
Title
Development of postnatal depression
Description
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.
Time Frame
Change from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
32020416
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.
Results Reference
background
PubMed Identifier
30815476
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.
Results Reference
background
PubMed Identifier
32210566
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.
Results Reference
background
PubMed Identifier
28258970
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.
Results Reference
background
PubMed Identifier
31411762
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.
Results Reference
background

Learn more about this trial

Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

We'll reach out to this number within 24 hrs