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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05579756
Other study ID # miscarriag
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2022
Est. completion date March 2023

Study information

Verified date October 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - all pregnant women 18:45 years old presented by intrauterine pregnancy loss before <= 26 weeks gestation Exclusion Criteria: - Ectopic pregnancy or vesicular mole - previous diagnosis of psychatric disorder - unwell to give consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage 1 year maximum
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