NCT05529381

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 26, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

November 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

September 2, 2022

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess stress, anxiety and depression symptoms in inpatients diagnosed to have placenta previa /accreta

    Depression Anxiety Stress Scale-21

    5 minutes

Secondary Outcomes (1)

  • Effects of depressive and anxiety symptoms on women functioning and quality of life

    10 minutes

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patient diagnosed to have placenta previa or accrete
  • plan to deliver baby in Assiut women health hospital
  • willing and able to participate

You may not qualify if:

  • pre-existing psychological disorders
  • severe medical complications
  • severe obstetric complications
  • fetal abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related 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.

    PMID: 25149040BACKGROUND
  • 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.

    PMID: 35388654BACKGROUND
  • 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.

    PMID: 34768164BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 33329843BACKGROUND
  • 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.

    PMID: 31138430BACKGROUND

Related Links

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

November 26, 2022

Primary Completion

June 6, 2024

Study Completion

November 6, 2024

Last Updated

November 8, 2024

Record last verified: 2024-02

Locations