AbortionNCT06742632
Comparative Psychiatric Problems Between First and Second Trimester Miscarriage
An observational study of Abortion, run by Assiut University at 1 site in Egypt.
Trial summary
Description of the psychiatric impact of miscarriage on women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion
- What is being tested?
- Symptoms checklist-90
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 1 Feb 2025
- How long will I take part?
- 1 Month
- 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 miscarrying women aged from 28 to 45 years less than or equal to 26 weeks gestation
Who may be able to join
- all miscarrying women less than or equal to 26 weeks gestation
Who cannot join
- ectopic pregnancy and vesicular mole
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
gellan karamallah Ahmed, lecturer of neurology and psyc contact
About this study
Official title: Comparative Study in Psychiatric Problems Among Mothers With Miscarriage in First and Second Trimester
Description of the psychiatric impact of miscarriage on women.
Read the detailed description
miscarriage, a significant reproductive health issue, often has profound psychological implications for women. The emotional and psychiatric effects of abortion can vary widely based on individual, cultural, and situational factors, as well as the timing of the procedure (1). First-trimester abortions are typically more common and are generally less complex medically, while second-trimester abortions often involve more intricate decision-making processes and greater societal and personal stigma (2).
Emerging evidence suggests that women undergoing abortions in different trimesters may experience distinct psychiatric challenges, including anxiety, depression, and post-traumatic stress disorder. However, the comparative psychological burden between first- and second-trimester abortions remains underexplored (3-6). Understanding these differences is crucial for tailoring mental health interventions and providing comprehensive care to affected women.
This study aims to compare the prevalence and types of psychiatric problems in mothers undergoing abortion in the first versus the second trimester, thereby contributing to the body of knowledge on maternal mental health and informing evidence-based support strategies.
- Conditions
- Abortion
- Being tested
- Symptoms checklist-90
- Keywords
- abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptoms checklist-90Behavioural
The Symptom Checklist-90 (SCL90) is a 90-item questionnaire used to assess psychological problems. The Symptom Checklist-90-Revised (SCL90R) is the revised version of the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| first trimester abortion | Not described Receives: Behavioral: Symptoms checklist-90 | |
| second trimester abortion | Not described Receives: Behavioral: Symptoms checklist-90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure psychiatric problems among the stuided groups
symptom checklist 90 "SCL 90'': It is a 90-item ques tionnaire used to assess psychological problems. Each item is scored on a scale from 0 to 4 based on how much an individual was bothered by each item. It has 9 subscales: (Somatization, Obsessive-compulsive, Inter personal sensibility, Depression, Anxiety, Anger-hostility, Phobic-anxi ety, Paranoid ideation, Psychoticism).
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies 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
- Prospective
- Enrolment
- 155 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742632
- Sponsor's protocol ID
- psychiatry issues in Abortion
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ayaulym N. Blushinova, Gulnara M. Shalgumbayeva, Duman Berikuly, Zaituna G. Khamidullina, Gaukhar A. Korganbayeva, Inabat N. Ordabayeva, Nazerke K. Sailauova ABB. Epidemiological aspects of pregnant losses. literature review. Sci Healthc J. 2023;25(2):236-43.
Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.
PubMed 34678403
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study in Psychiatric Problems Among Mothers With Miscarriage in First and Second Trimester
- ClinicalTrials.gov ID
- NCT06742632
- Acronym / sponsor ID
- psychiatry issues in Abortion
- Conditions
- Abortion
- Keywords
- abortion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 19 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.
Description of the psychiatric impact of miscarriage on women.
Detailed description
miscarriage, a significant reproductive health issue, often has profound psychological implications for women. The emotional and psychiatric effects of abortion can vary widely based on individual, cultural, and situational factors, as well as the timing of the procedure (1). First-trimester abortions are typically more common and are generally less complex medically, while second-trimester abortions often involve more intricate decision-making processes and greater societal and personal stigma (2).
Emerging evidence suggests that women undergoing abortions in different trimesters may experience distinct psychiatric challenges, including anxiety, depression, and post-traumatic stress disorder. However, the comparative psychological burden between first- and second-trimester abortions remains underexplored (3-6). Understanding these differences is crucial for tailoring mental health interventions and providing comprehensive care to affected women.
This study aims to compare the prevalence and types of psychiatric problems in mothers undergoing abortion in the first versus the second trimester, thereby contributing to the body of knowledge on maternal mental health and informing evidence-based support strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first trimester abortion | – | Behavioral: Symptoms checklist-90 |
| second trimester abortion | – | Behavioral: Symptoms checklist-90 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all miscarrying women aged from 28 to 45 years less than or equal to 26 weeks gestation
Key inclusion criteria (1 listed)
- all miscarrying women less than or equal to 26 weeks gestation
Key exclusion criteria (1 listed)
- ectopic pregnancy and vesicular mole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptoms checklist-90The Symptom Checklist-90 (SCL90) is a 90-item questionnaire used to assess psychological problems. The Symptom Checklist-90-Revised (SCL90R) is the revised version of the questionnaire. | Behavioural | first trimester abortion, second trimester abortion |
Primary outcome
measure psychiatric problems among the stuided groups
Time frame: through study completion, an average of 3 months
symptom checklist 90 "SCL 90'': It is a 90-item ques tionnaire used to assess psychological problems. Each item is scored on a scale from 0 to 4 based on how much an individual was bothered by each item. It has 9 subscales: (Somatization, Obsessive-compulsive, Inter personal sensibility, Depression, Anxiety, Anger-hostility, Phobic-anxi ety, Paranoid ideation, Psychoticism).
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 19 Dec 2024.
- Results publicationAyaulym N. Blushinova, Gulnara M. Shalgumbayeva, Duman Berikuly, Zaituna G. Khamidullina, Gaukhar A. Korganbayeva, Inabat N. Ordabayeva, Nazerke K. Sailauova ABB. Epidemiological aspects of pregnant losses. literature review. Sci Healthc J. 2023;25(2):236-43.
- Results publication: PubMed 34678403Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.
- Individual participant dataSharing planned: Undecided
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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.
gellan karamallah Ahmed, lecturer of neurology and psyc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, run by Assiut University at 1 site in Egypt.
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 1 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 gellan karamallah Ahmed, lecturer of neurology and psyc (gillankaram@aun.edu.eg, gillankaram@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure psychiatric problems among the stuided groups (time frame: through study completion, an average of 3 months). 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 NCT06742632, which also lists 2 linked publications.
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 19 Dec 2024.