Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is aimed to detect severe fear of delivery and its association with the incidence of obsessive-compulsive disorder and symptoms of depression and anxiety in the population of pregnant women in the third trimester during the serious COVID-19 pandemic situation in Slovakia. Data will be acquired from three departments of gynaecology and obstetrics of University Hospital Bratislava. The majority of pregnancies from the region are managed in this hospital; the total number of deliveries in 2020 achieved 7,835

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic

NCT04377412

Anxiety Depression Pregnancy Related

UNKNOWN

Birth Experience During COVID-19 Confinement

NCT04348929

Postpartum Depression

COMPLETED NA

Pregnancy Without Psychosocial Stress

NCT04853693

Depressive Symptoms Anxiety Disorders and Symptoms Depression, Postpartum

UNKNOWN NA

Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies

NCT05951738

Perinatal Depression

UNKNOWN NA

Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment

NCT06362486

Covid19 and Pregnancy

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The pregnancy is a risk factor for the first manifestation of several mental disorders. Current serious pandemic situation and a constant risk of COVID-19 infection negatively affects the mental state of the population, risk groups of pregnant women in particular. The aim of this project is to discover the incidence of symptoms of depression, anxiety and obsessive-compulsive disorder in association with the fear of delivery in current COVID-19 pandemic conditions in Slovakia. We also decided to add a short tool for detection of domestic violence among other scales to detect the incidence among Slovak pregnant population. All pregnant women in their third trimester who visit the prenatal clinic for their routine weekly check-up will be asked to participate in the study. The questionnaire which comprises of validated mental scales will be handed out to the patients waiting for their examination. After collection of filled questionnaires, those will be later paired with patients' medical documentation and statistically evaluated. The questionnaires will be collected during the period of 1.4.2021-31.3.2022 and statistical analysis will be conducted in the period of 1.4.2022-1.8.2022. It is expected that approximately 1,500 women will be included into the study. All three departments of gynaecology and obstetrics of the University Hospital Bratislava will participate at the study. In total, approximately 7,800 deliveries a year are managed in the University Hospital Bratislava.

Following questionnaires are planned to be used in the study:

* Wijma Delivery Expectancy/Experience Questionnaire - aimed at fear of delivery
* PASS (Perinatal Anxiety Screening Scale) - aimed at anxiety in women before and after delivery
* PHQ-9-SK (Patient Health Questionnaire) - aimed at depressive disorder
* HITS Domestic Violence Screening Tool - aimed at domestic violence
* DOK (The Obsessive-Compulsive Inventory) - aimed at obsessive and compulsive symptoms
* GAD-7 (General Anxiety Disorder-7) - aimed at general anxiety disorder
* EPDS (Edinburgh Postnatal Depression Scale) - aimed at symptoms of postpartal depression

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Woman

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire

questionnaire - the complex of 6 questionnaires aimed to recognize the fear of delivery, perinatal anxiety, depressive disorder, obsessive-compulsive disorder, general anxiety disorder, postpartal depression and domestic violence.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnancy after 34th week
* Vital fetus

Exclusion Criteria

* Unwilling to participate
* Age less than 18 years
* Foetus mortus or perinatal death of the newborn
* Low knowledge of Slovak language
* Serious pathology in the pregnancy (e.g. placenta praevia, known congenital disorders)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes