Hypertension With PregnancyNCT03503383
Evaluation of Psychological Status in Pregnant Women Complaining of Hypertension With Pregnancy
An observational study of Hypertension With Pregnancy, run by Zagazig University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension With Pregnancy
- What is being tested?
- Patient Health Questionnaire-9 and Generalized Anxiety Disorder Scale (GAD-7)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2018to 1 Dec 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Minya Health Insurance Hospital
Minya, 61111
Mena M Abdalla, MSc, +20101049414
Mena M Abdalla, MSc
- Recruiting
Zagazig University Hospitals
Zagazig
Mena M Abdalla, MSc, +201010494104
Mena M Abdalla, MSc
About this study
Official title: 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.
- Conditions
- Hypertension With Pregnancy
- Being tested
- Patient Health Questionnaire-9, Generalized Anxiety Disorder Scale (GAD-7)
- Keywords
- Hypertension with pregnancy, anxiety, depression, preeclampsia, mental health
- Medical subject headings
- Anxiety Disorders, Depression, Pre-Eclampsia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Health Questionnaire-9Behavioural
Also called PHQ-9 depression scale
PHQ-9 for assessing and monitoring depression severity
Generalized Anxiety Disorder Scale (GAD-7)Behavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | pregnant women without any medical disorders during pregnancy Receives: Behavioral: Patient Health Questionnaire-9; Behavioral: Generalized Anxiety Disorder Scale (GAD-7) | |
| Diseased group | Patients complaining of hypertension with pregnancy Receives: Behavioral: Patient Health Questionnaire-9; Behavioral: Generalized Anxiety Disorder Scale (GAD-7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Evaluation using Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 is used to assess number of participants with depression.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Mar 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension With PregnancyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mena Malak Saleeb Abdalla, Zagazig University
- Investigators
- Mena M Abdalla, MSc, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503383
- Sponsor's protocol ID
- MAbdalla1
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mental Health Status in Pregnant Women Complaining of Hypertension With Pregnancy
- ClinicalTrials.gov ID
- NCT03503383
- Acronym / sponsor ID
- MAbdalla1
- Conditions
- Hypertension With Pregnancy
- Keywords
- Hypertension with pregnancy, anxiety, depression, preeclampsia, mental health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled group | – | Behavioral: Patient Health Questionnaire-9, Behavioral: Generalized Anxiety Disorder Scale (GAD-7)pregnant women without any medical disorders during pregnancy |
| Diseased group | – | Behavioral: Patient Health Questionnaire-9, Behavioral: Generalized Anxiety Disorder Scale (GAD-7)Patients complaining of hypertension with pregnancy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- pregnant women
- Hypertensive pregnant women for diseased group
- Normal pregnancy with no medical disorders associated in controlled group
- singleton pregnancy
- spontaneous pregnancy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Health Questionnaire-9Also: PHQ-9 depression scalePHQ-9 for assessing and monitoring depression severity | Behavioural | Controlled group, Diseased group |
| Generalized Anxiety Disorder Scale (GAD-7)Also: GAD-7to 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 | Behavioural | Controlled group, Diseased group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mena M Abdalla, MSc principal investigator
Zagazig University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension With Pregnancy, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mena M Abdalla, MSc (+201010494104, dr.menasaleeb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Evaluation using Patient Health Questionnaire-9 (PHQ-9) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.