Evaluation of Psychological Status in Pregnant Women Complaining of Hypertension With Pregnancy

April 18, 2018 updated by: Mena Malak Saleeb Abdalla, Zagazig University

Evaluation of Mental Health Status in Pregnant Women Complaining of Hypertension With Pregnancy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Recruiting
        • Minya Health Insurance Hospital
        • Contact:
          • Mena M Abdalla, MSc
          • Phone Number: +20101049414
        • Principal Investigator:
          • Mena M Abdalla, MSc
      • Zagazig, Egypt
        • Recruiting
        • Zagazig University Hospitals
        • Principal Investigator:
          • Mena M Abdalla, MSc
        • Contact:
          • Mena M Abdalla, MSc
          • Phone Number: +201010494104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study is comparing between two groups, first group is healthy pregnant women and second group is pregnant women with hypertension . Both groups are assessed for both Anxiety and Depresion disorders.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controlled group
pregnant women without any medical disorders during pregnancy
Behavioral: Patient Health Questionnaire-9
PHQ-9 for assessing and monitoring depression severity
Other Names:
  • PHQ-9 depression scale
Behavioral: 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
Other Names:
  • GAD-7
Diseased group
Patients complaining of hypertension with pregnancy
Behavioral: Patient Health Questionnaire-9
PHQ-9 for assessing and monitoring depression severity
Other Names:
  • PHQ-9 depression scale
Behavioral: 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
Other Names:
  • GAD-7

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Mena M Abdalla, MSc, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAbdalla1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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