Anxiety and Depressive Symptoms in Placenta Previa / Accreta

Anxiety Depression Clinical Trial

Official title:

Anxiety and Depressive Symptoms of Pregnant Women Diagnosed to Have Placenta Previa / Accreta

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05529381
• Other study ID #: ADSPPP
• Status: Enrolling by invitation
• Start date: November 26, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 65
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• Anxiety Disorders
• Depression
• Placenta Previa

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta	Depression Anxiety Stress Scale-21	5 minutes
Secondary	Effects of depressive and anxiety symptoms on women functioning and quality of life	SF-12 questionnaire	10 minutes

External Links

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