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Quality of Life in Postpartum Women With Placenta Accrete Spectrum.

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ClinicalTrials.gov Identifier: NCT04583540
Recruitment Status : Not yet recruiting
First Posted : October 12, 2020
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Beshoy Atef Mounir Rizk, Assiut University

Study Description
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Brief Summary:
  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. to assess which factors are associated with quality of life and health state domains postpartum.

Condition or disease
Placenta Accrete Spectrum

Detailed Description:

The morbidly adherent placenta is abnormally adherent placenta to myometrium due to the absence of decidua basalis partially or totally in a way that prevents normal placental separation after delivery.

MAP includes a spectrum classified according to the extend of trophoblastic invasion to myometrium into (accrete, increta, percreta).

The greatest risk factor is previous uterine surgery mostly previous caesarian sections.

In the last decade incidence of placenta accrete spectrum has increased in direct proportion with increased rates of cesarean sections up to 1 per 500 pregnancies.

This rising incidence makes placenta accrete spectrum (PAS)one of the most serious problems in obstetrics with a high rate of complications peripartum and postpartum as well like (peripartum hysterectomy - intestinal injure- bladder injure - ureteral injure - ICU admission- massive blood transfusion) that may affect patients health outcome and their quality of life.

Diagnosis of PAS depends mainly on the history of antepartum hemorrhage and confirmed by the grayscale US with high sensitivity and specificity reaching up to 90%.

Medical service is no longer one-sided evaluated. Patient-centered care is a core in medical service.

Quality of life (QOL) and health status (HS) are important categories of patient-reported outcomes (PROs), in which the patient's perspective is key, and that can be used to assess the impact of current HS and to assess the efficiency of interventions. The difference between these PROs is that where HS refers to self-perceived physical, psychological, and social functioning, QOL also incorporates patients' evaluation of functioning, i.e. (dis)satisfaction with the aspects of life. Since health care is becoming more and more patient-centered, the assessment of the patient's subjective experience is considered to be essential for informed clinical decision-making and health policy. Therefore, research on QOL and HS in postpartum women is increasing, in which multiple contributing factors and interventions are examined.

The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.

The WHOQOL-Bref scoring assesses four domains of quality of life with 26 items 1_physical health, 2-psychological health, 3- social relationships, 4- environment.

The short form 36 ( SF-36) score is validated quality of life survey with 36 items to assess health outcome and quality of life through eight domains 1- physical functioning (PF), 2-role limitation due to the physical problem ( RP), 3-bodily pain (BP), 4- general health (GH), 5- vitality (VT), 6- social functioning (SF), 7- role limitation due to emotional problem (RE), 8- mental health (MH).

The objective of this research is to assess the quality of life in patients who had placenta accreta spectrum using WHOQOL-BREF scoring and SF-36 quality of life survey

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health Status and Quality of Life in Postpartum Women With Placenta Accrete Spectrum.
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Assess quality of life in patients had placenta accrete spectrum 6-8 weeks postpartum [ Time Frame: Baseline ]
    Use of SF-36 survey to assess quality of life in women had placenta accrete spectrum 6-8 weeks postpartum

  2. patients had placenta accrete spectrum 6-8 weeks postpartum [ Time Frame: Baseline ]
    Use of WHOQOL-bref scoring to assess quality of life in women had placenta accrete spectrum 6-8 weeks postpartum


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 1-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

Exclusion Criteria:

  1. Emergency CS before confirming MAP diagnosis.
  2. Preterm delivery (before 36 weeks in case of MAP)
  3. .peripartum hysterectomy for any cause other than MAP
  4. Other medical diseases that affect the quality of life
  5. Postpartum depression.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583540


Contacts
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Contact: Beshoy Atef Mounir 01285836093 batef0270@gmail.com
Contact: Sherif Mohammed Abdel-Mageed Badran 01009536255 doctorbadran1@yahoo.com

Locations
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Egypt
Faculty of medicine Assiut university
Assiut, Egypt
Contact: Beshoy Atef Mounir    01285836093      
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Beshoy Atef Mounir Rizk, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04583540    
Other Study ID Numbers: QOL placenta accrete
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No