Quality of Life in Postpartum Women With Placenta Accrete Spectrum.

Health Status and Quality of Life in Postpartum Women With Placenta Accrete Spectrum.

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (ACTUAL): October 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: QOL placenta accrete

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No