- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529381
Anxiety and Depressive Symptoms in Placenta Previa / Accreta
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Assiut, Egypt
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient diagnosed to have placenta previa or accrete
- plan to deliver baby in Assiut women health hospital
- willing and able to participate
Exclusion Criteria:
- pre-existing psychological disorders
- severe medical complications
- severe obstetric complications
- fetal abnormality
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta
Time Frame: 5 minutes
|
Depression Anxiety Stress Scale-21
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5 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of depressive and anxiety symptoms on women functioning and quality of life
Time Frame: 10 minutes
|
SF-12 questionnaire
|
10 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lovibond 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.
- 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.
- Crocetto 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.
- Jenabi 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.
- Park 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.
- Tol 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADSPPP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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