MiscarriageNCT05579756
Psychatric Impact of Miscarriage in Assiut University Hospital
An observational study of Miscarriage, run by Assiut University.
Trial summary
Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Miscarriage
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2023
- 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 18 to 45 years
- Women only
- Adult
Study population: - all pregnant women 18:45 years old presented by intrauterine pregnancy loss before <= 26 weeks gestation
Who may be able to join
- all pregnant women 18:45 years old presented by intrauterine pregnancy loss before <= 26 weeks gestation
Who cannot join
- Ectopic pregnancy or vesicular mole
- previous diagnosis of psychatric disorder
- unwell to give consent
About this study
Official title: Psychatric Impact of Miscarriage and Its Associated Factors Among Women in Assiut University Women's Health Hospital
Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).
Read the detailed description
Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).
While the clinical management of miscarriage and its physical complications have been extensively discussed; the psychological impact of this traumatic event of loss is usually overlooked especially in developing countries (8-11). Moreover, there are behind-the-scene factors that trigger or correlate to the development of psychiatric morbidities following miscarriage (12,13). Factors as sociodemographic, marital satisfaction, social support, individual's coping resources, history of infertility and previous miscarriage vary across different population samples, also vary in their influence on women's psychological resilience after traumatic events as miscarriage. No previous studies addressed this topic in Egyptian population.
- Conditions
- Miscarriage
- Medical subject headings
- Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage
Measured: 1 year maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- More trials run by Assiut 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579756
- Sponsor's protocol ID
- miscarriag
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychatric Impact of Miscarriage and Its Associated Factors Among Women in Assiut University Women's Health Hospital
- ClinicalTrials.gov ID
- NCT05579756
- Acronym / sponsor ID
- miscarriag
- Conditions
- Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Oct 2022 (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.
Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).
Detailed description
Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).
While the clinical management of miscarriage and its physical complications have been extensively discussed; the psychological impact of this traumatic event of loss is usually overlooked especially in developing countries (8-11). Moreover, there are behind-the-scene factors that trigger or correlate to the development of psychiatric morbidities following miscarriage (12,13). Factors as sociodemographic, marital satisfaction, social support, individual's coping resources, history of infertility and previous miscarriage vary across different population samples, also vary in their influence on women's psychological resilience after traumatic events as miscarriage. No previous studies addressed this topic in Egyptian population.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- - all pregnant women 18:45 years old presented by intrauterine pregnancy loss before <= 26 weeks gestation
Key inclusion criteria (1 listed)
- all pregnant women 18:45 years old presented by intrauterine pregnancy loss before <= 26 weeks gestation
Key exclusion criteria (3 listed)
- Ectopic pregnancy or vesicular mole
- previous diagnosis of psychatric disorder
- unwell to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage
Time frame: 1 year maximum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
Related trials for Miscarriage
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Recruiting
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage, run by Assiut University.
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 1 inclusion and 3 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage (time frame: 1 year maximum). 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 14 Oct 2022.