DepressionNCT04321564
Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
An observational study of Depression and Anxiety Depression, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety Depression, Pregnancy Early
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 30 Apr 2019
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Comparison of beck depression and anxiety values of nulliparous and multiparous pregnants who underwent optional abortion below 12 weeks and the effect of parity on depression and anxiety.
Who may be able to join
- healthy
- Women with a pregnancy less than 12 weeks
- no psychiatric disease or drug use
Who cannot join
- Those who have had a psychiatric diagnosis before,
- Women under the age of 18,
- Psychiatric drug users,
- Those who have experienced a major trauma or disease
- During the 3-month follow-up period, who developed complications during the procedure pregnant again
- Women with a pregnancy greater than 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.
Read the detailed description
The beck depression and anxiety scale consists of questionnaire questions asked to the patient, and the value on 17 indicates advanced depression.
The BDI inventory has maximum of 63 and minimum of 0 scores:
(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment
- Conditions
- Depression, Anxiety Depression, Pregnancy Early
- Keywords
- Beck Depression, Beck Anxiety, parite, curettage
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nullipar pregnant women | Not described | |
| multipar pregnant women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Beck Depression and Anxiety Scores in Multipar and Nulliparous Women who have gone under Dilatation and Curettage
to evaluate the effect of the parity on depression and anxiety.
The BDI inventory has maximum of 63 and minimum of 0 scores:
(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start20 Jan 2019
- Primary completion10 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321564
- Sponsor's protocol ID
- 2018.7.17
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
- ClinicalTrials.gov ID
- NCT04321564
- Acronym / sponsor ID
- 2018.7.17
- Conditions
- Depression, Anxiety Depression, Pregnancy Early
- Keywords
- Beck Depression, Beck Anxiety, parite, curettage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 25 Mar 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.
It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.
Detailed description
The beck depression and anxiety scale consists of questionnaire questions asked to the patient, and the value on 17 indicates advanced depression.
The BDI inventory has maximum of 63 and minimum of 0 scores:
(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nullipar pregnant women | – | – |
| multipar pregnant women | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Comparison of beck depression and anxiety values of nulliparous and multiparous pregnants who underwent optional abortion below 12 weeks and the effect of parity on depression and anxiety.
Key inclusion criteria (3 listed)
- healthy
- Women with a pregnancy less than 12 weeks
- no psychiatric disease or drug use
Key exclusion criteria (6 listed)
- Those who have had a psychiatric diagnosis before,
- Women under the age of 18,
- Psychiatric drug users,
- Those who have experienced a major trauma or disease
- During the 3-month follow-up period, who developed complications during the procedure pregnant again
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Beck Depression and Anxiety Scores in Multipar and Nulliparous Women who have gone under Dilatation and Curettage
Time frame: 3 months
to evaluate the effect of the parity on depression and anxiety. The BDI inventory has maximum of 63 and minimum of 0 scores: (0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment
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 31 Mar 2020.
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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?
An observational study of Depression and Anxiety Depression, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 6 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 31 Mar 2020. 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?
Comparison of Beck Depression and Anxiety Scores in Multipar and Nulliparous Women who have gone under Dilatation and Curettage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.