Anxiety DepressionNCT05529381
Anxiety and Depressive Symptoms in Placenta Previa / Accreta
An observational study of Anxiety Depression and Placenta Previa, run by Assiut University at 1 site in Egypt.
Trial summary
placenta previa is an obstetric complication which is associated with depression and anxiety. As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anxiety Depression, Placenta Previa
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2022to 6 Nov 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women diagnosed to have placenta previa / accreta in Inpatient ward Assuit women health hospital
Who may be able to join
- patient diagnosed to have placenta previa or accrete
- plan to deliver baby in Assiut women health hospital
- willing and able to participate
Who cannot join
- pre-existing psychological disorders
- severe medical complications
- severe obstetric complications
- fetal abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety and Depressive Symptoms of Pregnant Women Diagnosed to Have Placenta Previa / Accreta
placenta previa is an obstetric complication which is associated with depression and anxiety.
As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother
Read the detailed description
Placenta previa is an obstetric complication with a prevalence of 5.2 per 1000 pregnancies. placenta previa is associated with maternal morbidity and mortality. The delivery carries a risk of bleeding, emergency hysterectomy, organ damage and even death. During admission, counselling is done for the possible need for delivery at any time and the need for life saving hysterectomy. hysterectomy is a tough and difficult choice for patients, and the subsequent emotional process is often associated with depression, severe and prolonged feelings of sadness, diminished interest in activities and in sexual intercourse. Similarly, severe adverse psychological outcomes, including post-traumatic stress disorders, have been reported as a result of traumatic birth events. Antenatal depression and anxiety occur in approximately 13% and up to 21.7% of women, respectively. Rates of antenatal depression among women hospitalized for obstetrical risk can be as high as 19%.
Research about the responses to a diagnosis of placenta previa is scarce. A study found increased anxiety score in women diagnosed with Placenta accreta spectrum. Other studies focussed on the post-trauma stress associated with hysterectomy versus uterine conservation.
As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother.
- Conditions
- Anxiety Depression, Placenta Previa
- Medical subject headings
- Placenta Previa
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta
Depression Anxiety Stress Scale-21
Measured: 5 minutes
Secondary outcomes (1)
Effects of depressive and anxiety symptoms on women functioning and quality of life
SF-12 questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start26 Nov 2022
- Primary completion6 Jun 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AM Abdelbary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529381
- Sponsor's protocol ID
- ADSPPP
- Status last verified
- Feb 2024
- First submitted
- 2 Sep 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Byatt N, Hicks-Courant K, Davidson A, Levesque R, Mick E, Allison J, Moore Simas TA. Depression and anxiety among high-risk obstetric inpatients. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):644-9. doi: 10.1016/j.genhosppsych.2014.07.011. Epub 2014 Jul 27.
PubMed 25149040Crocetto F, Barone B, Bonito E, Maggi M, Caputo VF, di Girolamo A, Trama F, di Spiezio Sardo A, Zizolfi B. Psychological impact of abnormally invasive placenta: an underestimated and hidden morbidity. J Basic Clin Physiol Pharmacol. 2022 Apr 8;33(5):649-653. doi: 10.1515/jbcpp-2021-0384. eCollection 2022 Sep 1.
PubMed 35388654Jenabi E, Salimi Z, Bashirian S, Khazaei S, Ayubi E. The risk factors associated with placenta previa: An umbrella review. Placenta. 2022 Jan;117:21-27. doi: 10.1016/j.placenta.2021.10.009. Epub 2021 Oct 20.
PubMed 34768164Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Park HS, Cho HS. Management of massive hemorrhage in pregnant women with placenta previa. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):409-416. doi: 10.17085/apm.20076.
PubMed 33329843Tol ID, Yousif M, Collins SL. Post traumatic stress disorder (PTSD): The psychological sequelae of abnormally invasive placenta (AIP). Placenta. 2019 Jun;81:42-45. doi: 10.1016/j.placenta.2019.04.004. Epub 2019 Apr 16.
PubMed 31138430
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depressive Symptoms of Pregnant Women Diagnosed to Have Placenta Previa / Accreta
- ClinicalTrials.gov ID
- NCT05529381
- Acronym / sponsor ID
- ADSPPP
- Conditions
- Anxiety Depression, Placenta Previa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 7 Sep 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.
placenta previa is an obstetric complication which is associated with depression and anxiety.
As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother
Detailed description
Placenta previa is an obstetric complication with a prevalence of 5.2 per 1000 pregnancies. placenta previa is associated with maternal morbidity and mortality. The delivery carries a risk of bleeding, emergency hysterectomy, organ damage and even death. During admission, counselling is done for the possible need for delivery at any time and the need for life saving hysterectomy. hysterectomy is a tough and difficult choice for patients, and the subsequent emotional process is often associated with depression, severe and prolonged feelings of sadness, diminished interest in activities and in sexual intercourse. Similarly, severe adverse psychological outcomes, including post-traumatic stress disorders, have been reported as a result of traumatic birth events. Antenatal depression and anxiety occur in approximately 13% and up to 21.7% of women, respectively. Rates of antenatal depression among women hospitalized for obstetrical risk can be as high as 19%.
Research about the responses to a diagnosis of placenta previa is scarce. A study found increased anxiety score in women diagnosed with Placenta accreta spectrum. Other studies focussed on the post-trauma stress associated with hysterectomy versus uterine conservation.
As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women diagnosed to have placenta previa / accreta in Inpatient ward Assuit women health hospital
Key inclusion criteria (3 listed)
- patient diagnosed to have placenta previa or accrete
- plan to deliver baby in Assiut women health hospital
- willing and able to participate
Key exclusion criteria (4 listed)
- pre-existing psychological disorders
- severe medical complications
- severe obstetric complications
- fetal abnormality
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
Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta
Time frame: 5 minutes
Depression Anxiety Stress Scale-21
1 secondary outcome
Effects of depressive and anxiety symptoms on women functioning and quality of life
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 25149040Byatt N, Hicks-Courant K, Davidson A, Levesque R, Mick E, Allison J, Moore Simas TA. Depression and anxiety among high-risk obstetric inpatients. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):644-9. doi: 10.1016/j.genhosppsych.2014.07.011. Epub 2014 Jul 27.
- Background: PubMed 35388654Crocetto F, Barone B, Bonito E, Maggi M, Caputo VF, di Girolamo A, Trama F, di Spiezio Sardo A, Zizolfi B. Psychological impact of abnormally invasive placenta: an underestimated and hidden morbidity. J Basic Clin Physiol Pharmacol. 2022 Apr 8;33(5):649-653. doi: 10.1515/jbcpp-2021-0384. eCollection 2022 Sep 1.
- Background: PubMed 34768164Jenabi E, Salimi Z, Bashirian S, Khazaei S, Ayubi E. The risk factors associated with placenta previa: An umbrella review. Placenta. 2022 Jan;117:21-27. doi: 10.1016/j.placenta.2021.10.009. Epub 2021 Oct 20.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 33329843Park HS, Cho HS. Management of massive hemorrhage in pregnant women with placenta previa. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):409-416. doi: 10.17085/apm.20076.
- Background: PubMed 31138430Tol ID, Yousif M, Collins SL. Post traumatic stress disorder (PTSD): The psychological sequelae of abnormally invasive placenta (AIP). Placenta. 2019 Jun;81:42-45. doi: 10.1016/j.placenta.2019.04.004. Epub 2019 Apr 16.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Anxiety Depression and Placenta Previa, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta (time frame: 5 minutes). 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 NCT05529381, which also lists 6 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 8 Nov 2024.