Placenta Accrete SpectrumNCT04583540
Quality of Life in Postpartum Women With Placenta Accrete Spectrum.
An observational study of Placenta Accrete Spectrum, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accrete Spectrum
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: All women have confirmed diagnosis of placenta accrete spectrum by Doppler abdominal ultrasound termination of pregnancy by elective cs after fullterm.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine Assiut university
Asyut
Beshoy Atef Mounir, 01285836093
About this study
Official title: Health Status and Quality of Life in Postpartum Women With Placenta Accrete Spectrum.
- 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.
- to assess which factors are associated with quality of life and health state domains postpartum.
Read the 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
- Conditions
- Placenta Accrete Spectrum
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accrete SpectrumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Atef Mounir Rizk, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583540
- Sponsor's protocol ID
- QOL placenta accrete
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2020
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status and Quality of Life in Postpartum Women With Placenta Accrete Spectrum.
- ClinicalTrials.gov ID
- NCT04583540
- Acronym / sponsor ID
- QOL placenta accrete
- Conditions
- Placenta Accrete Spectrum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- to assess which factors are associated with quality of life and health state domains postpartum.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All women have confirmed diagnosis of placenta accrete spectrum by Doppler abdominal ultrasound termination of pregnancy by elective cs after fullterm.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accrete Spectrum, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beshoy Atef Mounir (01285836093, batef0270@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess quality of life in patients had placenta accrete spectrum 6-8 weeks postpartum (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.