Anxiety and Depressive Symptoms in Placenta Previa / Accreta | NCT05529381

Studies
Anxiety and Depressive Symptoms in Placenta Previa / Accreta

NCT05529381

Sponsor

Assiut University

Status

Completed

Last Update Posted

Nov 8, 2024Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Anxiety Depression
Placenta Previa

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2022Actual

Primary Completion Date

Jun 6, 2024Actual

Completion Date

Nov 6, 2024Actual

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 2, 2022

First Posted Date

Sep 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2024

Last Update Posted Date

Nov 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta	Depression Anxiety Stress Scale-21	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Effects of depressive and anxiety symptoms on women functioning and quality of life	SF-12 questionnaire	10 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

pregnant women diagnosed to have placenta previa / accreta in Inpatient ward Assuit women health hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25149040	Background	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.
35388654	Background	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.

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases