Ectopic PregnancyNCT06721403
Psychatric Effect of Ectopic Pregnancy
An observational study of Ectopic Pregnancy, run by Assiut University.
Trial summary
Assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy Determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Study population: All pregnant women 18:45 years old presented with ectopic pregnancy
Who may be able to join
- All pregnant woman 18:45 years old presented with ectopic pregnancy.
Who cannot join
- intrauterine pregnancy
- previous diagnosis of psychiatric disorders
- Unwell to give consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Anxiety,Depressive Symptoms &PTSD in Cases of Post Ectopic Pregnancy
Assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy Determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy
Read the detailed description
Ectopic pregnancy is any pregnancy in which the fertilized ovum implants outside the intrauterine cavity. More than 95 percent of ectopic pregnancies occur in the fallopian tubes.
Another 2.5 percent occur in the cornua of the uterus, and the remainder are found in the ovary, cervix or abdominal cavity.
Ectopic pregnancy causes major maternal morbidity and mortality, with pregnancy loss, and its incidence is increasing worldwide.
Previous ectopic pregnancy becomes a more significant risk factor with each successive occurrence. With one previous ectopic pregnancy treated by linear salpingostomy, the recurrence rate ranges from 15 to 20 percent, depending on the integrity of the contralateral tube.
The unanticipated and sudden loss of a pregnancy can be a devastating and traumatic experience resulting in high levels of psychological morbidity for some women.
EPLs can significantly contribute to the overall burden of psychopathology within a population. Recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. Further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial"
- Conditions
- Ectopic Pregnancy
- Medical subject headings
- Pregnancy, Ectopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ectopic pregnancy
Prevalence of anxiety,depressive symptoms and post-traumatic stress disorder after ectopic pregnancy
Measured: Within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Reda Youssef, Assiut University
- Investigators
- Ahmed Abbas, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721403
- Sponsor's protocol ID
- Anxiety post ectopic pregnancy
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Farren J, Jalmbrant M, Ameye L, Joash K, Mitchell-Jones N, Tapp S, Timmerman D, Bourne T. Post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy: a prospective cohort study. BMJ Open. 2016 Nov 2;6(11):e011864. doi: 10.1136/bmjopen-2016-011864.
PubMed 27807081
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anxiety,Depressive Symptoms &PTSD in Cases of Post Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT06721403
- Acronym / sponsor ID
- Anxiety post ectopic pregnancy
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
Assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy Determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy
Detailed description
Ectopic pregnancy is any pregnancy in which the fertilized ovum implants outside the intrauterine cavity. More than 95 percent of ectopic pregnancies occur in the fallopian tubes.
Another 2.5 percent occur in the cornua of the uterus, and the remainder are found in the ovary, cervix or abdominal cavity.
Ectopic pregnancy causes major maternal morbidity and mortality, with pregnancy loss, and its incidence is increasing worldwide.
Previous ectopic pregnancy becomes a more significant risk factor with each successive occurrence. With one previous ectopic pregnancy treated by linear salpingostomy, the recurrence rate ranges from 15 to 20 percent, depending on the integrity of the contralateral tube.
The unanticipated and sudden loss of a pregnancy can be a devastating and traumatic experience resulting in high levels of psychological morbidity for some women.
EPLs can significantly contribute to the overall burden of psychopathology within a population. Recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. Further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial"
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All pregnant women 18:45 years old presented with ectopic pregnancy
Key inclusion criteria (1 listed)
- All pregnant woman 18:45 years old presented with ectopic pregnancy.
Key exclusion criteria (3 listed)
- intrauterine pregnancy
- previous diagnosis of psychiatric disorders
- 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
Effect of ectopic pregnancy
Time frame: Within one week
Prevalence of anxiety,depressive symptoms and post-traumatic stress disorder after ectopic pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 27807081Farren J, Jalmbrant M, Ameye L, Joash K, Mitchell-Jones N, Tapp S, Timmerman D, Bourne T. Post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy: a prospective cohort study. BMJ Open. 2016 Nov 2;6(11):e011864. doi: 10.1136/bmjopen-2016-011864.
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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.
Ahmed Abbas, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, 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: opening soon, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina R Youssef, Bachelor (+20 01288575747, marinareda642@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ectopic pregnancy (time frame: Within one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06721403, which also lists 1 linked publication.
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 6 Dec 2024.