Pregnancy RelatedNCT04565730
Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery
A study testing Grup I= General anesthesia group and Grup II= Spinal anesthesia group in people with Pregnancy Related, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Grup I= General anesthesia group and Grup II= Spinal anesthesia group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2020to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 21-50 years old
- 36 gestational weeks or more,
- American Society of Anesthesiologists' (ASA) I and II
- Able to communicate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Effect of Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery: a Prospective 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Grup I= General anesthesia group, Grup II= Spinal anesthesia group
- Keywords
- Anesthesia, Postnatal depression, Cesarean delivery
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grup I= General anesthesia groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Grup II= Spinal anesthesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start27 Oct 2020
- Primary completion30 Jul 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. The first group is general anesthesia group. The second one is spinal anesthesia group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565730
- Sponsor's protocol ID
- Medipol Hospital 16
- Status last verified
- Aug 2023
- First submitted
- 16 Sep 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
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.
PubMed 32020416Kaya 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.
PubMed 30815476Chan 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.
PubMed 32210566Zanardo 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.
PubMed 28258970Yu 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.
PubMed 31411762
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery: a Prospective Study
- ClinicalTrials.gov ID
- NCT04565730
- Acronym / sponsor ID
- Medipol Hospital 16
- Conditions
- Pregnancy Related
- Keywords
- Anesthesia, Postnatal depression, Cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is general anesthesia group. The second one is spinal anesthesia group
| Arm | Type | Receives |
|---|---|---|
| Grup I= General anesthesia group | Active comparator | Other: Grup I= General anesthesia groupAfter 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. |
| Grup II= Spinal anesthesia group | Active comparator | Other: Grup II= Spinal anesthesia groupA 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 21-50 years old
- 36 gestational weeks or more,
- American Society of Anesthesiologists' (ASA) I and II
- Able to communicate
Key exclusion criteria (8 listed)
- history of bipolar or psychotic disorder
- suicidal state
- Chronic pain syndrome
- Intraoperative complication
- drug and/or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grup I= General anesthesia groupPreoperative 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. | Other | Grup I= General anesthesia group |
| Grup II= Spinal anesthesia groupPreoperative 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. | Other | Grup II= Spinal anesthesia group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 32020416Munro 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.
- Background: PubMed 30815476Kaya 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.
- Background: PubMed 32210566Chan 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.
- Background: PubMed 28258970Zanardo 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.
- Background: PubMed 31411762Yu 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.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grup I= General anesthesia group and Grup II= Spinal anesthesia group in people with Pregnancy Related, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of postnatal depression (time frame: Change from baseline Edinburgh Postnatal Depression Scale (EPDS) before discharge, 1 months and 3 months days after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565730, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.