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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04321564
Other study ID # 2018.7.17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2019
Est. completion date April 30, 2019

Study information

Verified date March 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date April 30, 2019
Est. primary completion date April 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy

- Women with a pregnancy less than 12 weeks

- no psychiatric disease or drug use

Exclusion Criteria:

- 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

Study Design


Locations

Country Name City State
Turkey Yalçin Bahat Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
3 months
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