NCT05579756

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage

    1 year maximum

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

\- all pregnant women 18:45 years old presented by intrauterine pregnancy loss before \<= 26 weeks gestation

You may qualify if:

  • all pregnant women 18:45 years old presented by intrauterine pregnancy loss before \<= 26 weeks gestation

You may not qualify if:

  • Ectopic pregnancy or vesicular mole
  • previous diagnosis of psychatric disorder
  • unwell to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

October 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

October 14, 2022

Record last verified: 2022-10