NCT04583540

Brief Summary

  1. 1.The objective of this study is to provide an overview of the core domains (physical,psychological,social) of quality of life and health state in postpartum women after the placenta accrete spectrum.
  2. 2.to assess which factors are associated with quality of life and health state domains postpartum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 23, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 7, 2021

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 23, 2020

Last Update Submit

May 5, 2021

Conditions

Placenta Accrete Spectrum

Outcome Measures

Primary Outcomes (2)

  • Assess quality of life in patients had placenta accrete spectrum 6-8 weeks postpartum

    Use of SF-36 survey to assess quality of life in women had placenta accrete spectrum 6-8 weeks postpartum

    Baseline

  • patients had placenta accrete spectrum 6-8 weeks postpartum

    Use of WHOQOL-bref scoring to assess quality of life in women had placenta accrete spectrum 6-8 weeks postpartum

    Baseline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All women have confirmed diagnosis of placenta accrete spectrum by Doppler abdominal ultrasound termination of pregnancy by elective cs after fullterm.

You may qualify if:

  • Confirmed diagnosis of MAP. 2-Termination of pregnancy after 36 weeks gestation 3-Peripartum hysterectomy for MAP. 4- Complicated CS without hysterectomy 5-Maternal age between 18 and 45 yrs 6-No other medical diseases

You may not qualify if:

  • Emergency CS before confirming MAP diagnosis.
  • Preterm delivery (before 36 weeks in case of MAP)
  • peripartum hysterectomy for any cause other than MAP
  • Other medical diseases that affect the quality of life
  • Postpartum depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut university

Asyut, Egypt

Location

Central Study Contacts

Beshoy Atef Mounir

CONTACT

01285836093batef0270@gmail.com

Sherif Mohammed Abdel-Mageed Badran

CONTACT

01009536255doctorbadran1@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 12, 2020

Study Start

June 1, 2021

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

May 7, 2021

Record last verified: 2020-10

Locations

EG(1)