Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

NCT04565730 | Completed

• 1 other identifier: Medipol Hospital 16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Anesthesia; Postnatal depression; Cesarean delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.

Study Arms (2)

Grup I= General anesthesia group

ACTIVE COMPARATOR

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.

Other: Grup I= General anesthesia group

Grup II= Spinal anesthesia group

ACTIVE COMPARATOR

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.

Other: Grup II= Spinal anesthesia group

Interventions

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 I= General anesthesia group

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.

Grup II= Spinal anesthesia group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32020416 BACKGROUND

• 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.

  PMID: 30815476 BACKGROUND

• 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.

  PMID: 32210566 BACKGROUND

• 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.

  PMID: 28258970 BACKGROUND

• 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.

  PMID: 31411762 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

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

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 25, 2020
• Study Start: October 27, 2020
• Primary Completion: July 30, 2023
• Study Completion: August 10, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)