Placenta AccretaNCT06717997
The Placental Thickness and Pregnancy Outcomes in Placenta Previa Women
A study testing ultrasound in people with Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women from 32-34 weeks.
- Pregnant women with singleton pregnancy.
- Women with placenta previa.
- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- Women without any medical disorders.
- Women should be living in a nearby area to make follow-up and early transportation is reasonably possible.
Who cannot join
- Women with severe bleeding necessitate immediate delivery.
- Women with confirmed fetal malformation.
- If associated with abruptio placentae.
- Women who will refuse to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Third-trimester Placental Thickness and Pregnancy Outcomes in Placenta Previa Women
Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. The diagnosis of placenta previa is done by trans-abdominal and trans-vaginal ultrasonography, which can document the placental edge's relationship to the internal os. Placenta accreta spectrum disorder is defined when trophoblastic invades the myometrium. The Placenta accreta spectrum can be categorized as: placenta accreta, placenta increta, and placenta percreta.
The clinical utility of placental thickness is an area of ongoing research in placenta previa. Prior studies have demonstrated an association between mid-trimester placental thickness and placenta accreta spectrum. Despite the presence of many studies in characterizing placental thickness, most studies have focused primarily on the placental accreta spectrum lacking information about other fetal and maternal complications. Symptomatic (bleeding) placenta previa is associated with increased maternal and neonatal morbidity and mortality. In addition; the mechanism that involves bleeding is unclear. It is usually related to uterine contractions, cervical effacement, and dilation leading to separation of the placenta from the underlying decidua.
- Conditions
- Placenta Accreta
- Being tested
- ultrasound
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
The placenta thickness will be performed on transabdominal images obtained in a longitudinal plane. Three measurements will be performed at the thickest portion of the placenta. The average of these three measurements was used for statistical analysis. The cohorts will be classified into 1) thick placenta (>4 cm) and average placenta (2-4 cm).
| Study group | Role | What they receive |
|---|---|---|
| Normal placental thickness women | Other | Not described Receives: Other: ultrasound |
| High placental thickness women | Other | Not described Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women with placenta accreta
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717997
- Sponsor's protocol ID
- PAS-US
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Third-trimester Placental Thickness and Pregnancy Outcomes in Placenta Previa Women
- ClinicalTrials.gov ID
- NCT06717997
- Acronym / sponsor ID
- PAS-US
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Dec 2024 (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.
Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. The diagnosis of placenta previa is done by trans-abdominal and trans-vaginal ultrasonography, which can document the placental edge's relationship to the internal os. Placenta accreta spectrum disorder is defined when trophoblastic invades the myometrium. The Placenta accreta spectrum can be categorized as: placenta accreta, placenta increta, and placenta percreta.
The clinical utility of placental thickness is an area of ongoing research in placenta previa. Prior studies have demonstrated an association between mid-trimester placental thickness and placenta accreta spectrum. Despite the presence of many studies in characterizing placental thickness, most studies have focused primarily on the placental accreta spectrum lacking information about other fetal and maternal complications. Symptomatic (bleeding) placenta previa is associated with increased maternal and neonatal morbidity and mortality. In addition; the mechanism that involves bleeding is unclear. It is usually related to uterine contractions, cervical effacement, and dilation leading to separation of the placenta from the underlying decidua.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal placental thickness women | Other | Other: ultrasound |
| High placental thickness women | Other | Other: ultrasound |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women from 32-34 weeks.
- Pregnant women with singleton pregnancy.
- Women with placenta previa.
- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- Women without any medical disorders.
Key exclusion criteria (4 listed)
- Women with severe bleeding necessitate immediate delivery.
- Women with confirmed fetal malformation.
- If associated with abruptio placentae.
- Women who will refuse to participate.
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 |
|---|---|---|
| ultrasoundThe placenta thickness will be performed on transabdominal images obtained in a longitudinal plane. Three measurements will be performed at the thickest portion of the placenta. The average of these three measurements was used for statistical analysis. The cohorts will be classified into 1) thick placenta (>4 cm) and average placenta (2-4 cm). | Other | High placental thickness women, Normal placental thickness women |
Primary outcome
number of women with placenta accreta
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
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Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
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Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
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Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Placenta Accreta, 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
number of women with placenta accreta (time frame: 3 weeks). 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 5 Dec 2024.