NCT04321564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 23, 2020

Last Update Submit

March 29, 2020

Conditions

DepressionAnxiety DepressionPregnancy Early

Keywords

Beck DepressionBeck Anxietyparitecurettage

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nullipar pregnant women

multipar pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • healthy
  • Women with a pregnancy less than 12 weeks
  • no psychiatric disease or drug use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalçın Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

January 20, 2019

Primary Completion

April 10, 2019

Study Completion

April 30, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

TU(1)