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

NCT03503383 | Unknown DMC

• 1 other identifier: MAbdalla1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension With Pregnancy

Keywords

Hypertension with pregnancy; anxiety; depression; preeclampsia; mental health

Outcome Measures

Primary Outcomes (2)

• Depression Evaluation using Patient Health Questionnaire-9 (PHQ-9)

  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)

  Generalized Anxiety Disorder Scale (GAD-7) is used to assess number of participants with anxiety disorders.

  6 months

Study Arms (2)

Controlled group

pregnant women without any medical disorders during pregnancy

Behavioral: Patient Health Questionnaire-9; Behavioral: Generalized Anxiety Disorder Scale (GAD-7)

Diseased group

Patients complaining of hypertension with pregnancy

Behavioral: Patient Health Questionnaire-9; Behavioral: Generalized Anxiety Disorder Scale (GAD-7)

Interventions

Patient Health Questionnaire-9 BEHAVIORAL

PHQ-9 for assessing and monitoring depression severity

Also known as: PHQ-9 depression scale

Controlled group; Diseased group

Generalized Anxiety Disorder Scale (GAD-7) BEHAVIORAL

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

Also known as: GAD-7

Controlled group; Diseased group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: This study only includes pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Minya Health Insurance Hospital

Minya, 61111, Egypt

RECRUITING

Zagazig University Hospitals

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pre-Eclampsia; Psychological Well-Being

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mena M Abdalla, MSc

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mena M Abdalla, MSc

CONTACT

+201010494104; dr.menasaleeb@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 19, 2018
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

EG (2)