Improving Quality of LifeNCT02878187
Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta
An observational study of Improving Quality of Life, run by Assiut University at 1 site in Egypt.
Trial summary
Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Improving Quality of Life
- What is being tested?
- Doppler
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2017to May 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women delivered by elective/emergency cesarean section due to placenta previa/accreta during the study period will be included in the study.
Who may be able to join
- Women Age 18-40 years
- Gestational age of pregnancy 28-40 weeks
- Diagnosed antenatally as placenta previa/accreta
- Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
- Women who will accept to participate in the study and are reliable for follow-up
Who cannot join
- 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta
Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation
Read the detailed description
No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate
- Conditions
- Improving Quality of Life
- Being tested
- Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopplerDevice
Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:
The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum
| Study group | Role | What they receive |
|---|---|---|
| placenta previa | all women managed by conservative surgical techniques during cesarean section after intraoperative hemorrhage due to placenta previa/accreta Receives: Device: Doppler | |
| healthy controls | women delivered by Cesarean for any other indication with no intraoperative hemorrhage or any additional surgical techniques performed during Cesarean Receives: Device: Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in the uterine arteries diameters in both groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start15 Jan 2017
- Primary completionDec 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Quality of LifeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
- Investigators
- Ahmed Abbas, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878187
- Sponsor's protocol ID
- PP
- Status last verified
- May 2020
- First submitted
- 22 Aug 2016
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta
- ClinicalTrials.gov ID
- NCT02878187
- Acronym / sponsor ID
- PP
- Conditions
- Improving Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation
Detailed description
No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placenta previa | – | Device: Dopplerall women managed by conservative surgical techniques during cesarean section after intraoperative hemorrhage due to placenta previa/accreta |
| healthy controls | – | Device: Dopplerwomen delivered by Cesarean for any other indication with no intraoperative hemorrhage or any additional surgical techniques performed during Cesarean |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women delivered by elective/emergency cesarean section due to placenta previa/accreta during the study period will be included in the study.
Key inclusion criteria (5 listed)
- Women Age 18-40 years
- Gestational age of pregnancy 28-40 weeks
- Diagnosed antenatally as placenta previa/accreta
- Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
- Women who will accept to participate in the study and are reliable for follow-up
Key exclusion criteria (1 listed)
- 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DopplerColor Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated: The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum | Device | healthy controls, placenta previa |
Primary outcome
The mean difference in the uterine arteries diameters in both groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Abbas, MD principal investigator
Assiut University
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 Improving Quality of Life, 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 13 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference in the uterine arteries diameters in both groups (time frame: 3 months). 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 13 May 2020.