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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03503383
Other study ID # MAbdalla1
Secondary ID
Status Recruiting
Phase
First received March 26, 2018
Last updated April 18, 2018
Start date March 1, 2018
Est. completion date December 1, 2018

Study information

Verified date April 2018
Source Zagazig University
Contact Mena M Abdalla, MSc
Phone +201010494104
Email dr.menasaleeb@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is a case controlled study comparing mental health status and some psychological impacts between two groups of patients first group is pregnant women without any other medical disorder during pregnancy,the second group is pregnant women complaining of hypertension with pregnancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- pregnant women

- Hypertensive pregnant women for diseased group

- Normal pregnancy with no medical disorders associated in controlled group

- singleton pregnancy

- spontaneous pregnancy

- patients who are not divorced or not widow

Exclusion Criteria:

- non-pregnant women

- any other associated medical disorder with pregnancy rather than Hypertension

- any known psychological or mental disorder prior to pregnancy

- non spontaneous pregnancy as those whom conceived by IVF

- Twin or more pregnancy

- patients who are divorced or widow

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient Health Questionnaire-9
PHQ-9 for assessing and monitoring depression severity
Generalized Anxiety Disorder Scale (GAD-7)
to diagnose generalized anxiety disorder, the GAD-7 also proved to have good sensitivity and specificity as a screener for panic, social anxiety, and post-traumatic stress disorder

Locations

Country Name City State
Egypt Minya Health Insurance Hospital Minya
Egypt Zagazig University Hospitals Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Evaluation using Patient Health Questionnaire-9 (PHQ-9) Patient Health Questionnaire-9 is used to assess number of participants with depression. 6 months
Primary Anxiety Evaluation using Generalized Anxiety Disorder Scale-7 (GAD-7) Generalized Anxiety Disorder Scale (GAD-7) is used to assess number of participants with anxiety disorders. 6 months