Placenta AccretaNCT06248385
Lower Placental Edge Thickness in Relation to Gestational Age at Delivery in Placenta Accreta (Prospective Cohort Study)
An observational study of Placenta Accreta, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of our study is to determine correlation between lower placental edge thickness measured by ultrasound and gestational age at delivery and predict the risk of emergency preterm birth in patients having placenta previa accreta. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- 2D ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2024to Mar 2025
- 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: This study will be carried out on 50 women with a singleton pregnancy, between 28-36 weeks, with placenta previa accreta by suspected sonographic examination.
Who may be able to join
- Single, viable gestations. Gestational age >28 weeks, < 36 weeks.
- Confirmed diagnosis of placenta previa accreta when the placenta lies directly over the internal os based on ultrasound features among RCOG criteria as follows) RCOG,2019):
- 2D greyscale signs: loss of myometrial interface or retroplacental clear space, reduced myometrial thickness, intra-placental blood flow and intra-placental lacunae.
- 2D color Doppler signs: intra-placental blood flow, the presence of altered blood flow in the retroplacental space and aberrant vessels crossing between placental surfaces.
- First time of diagnosis of placenta previa accreta is 28-30 weeks. Previous one or more cesarean sections.
Who cannot join
- Maternal medical co-morbidities like diabetes and hypertension. Patients with bleeding disorders or anticoagulant therapy. Over distended uterus e.g.: multiple gestation, polyhydramnios, fetal macrosomia(>4.5kg).
- Fetal anomalies or fetal growth restriction. Emergency cesarean section due to fetal distress. Rupture of membranes, intra-amniotic infection and fever during admission (>38 °C).
- History of cervical cerclage or cervical cone biopsy.
Trial locations and contacts
1 site in 1 country.
Alaa Said, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospitals
Cairo
Rehab Abdel Rahman
About this study
Official title: The Correlation of the Lower Placental Edge Thickness in Relation to Gestational Age at Delivery by Using Ultrasonography in Patients With Placenta Previa Accreta; A Prospective Cohort Study
The aim of our study is to determine correlation between lower placental edge thickness measured by ultrasound and gestational age at delivery and predict the risk of emergency preterm birth in patients having placenta previa accreta.
Read the detailed description
In pregnant women with placenta previa accreta, the lower placental edge thickness measured by ultrasound may correlate with gestational age at delivery and predict emergency preterm cesarean delivery. Thick lower placental edge is thought to be responsible for emergency preterm birth.
All women who meet the inclusion criteria will undergo full assessment to identify eligible women.
This assessment will include:
Detailed History:Personal history: age, duration of marriage, smoking. Present history: any current medical or surgical diseases and current medication.
Past medical history: history of medical disorders like diabetes and hypertension.
Surgical history: previous uterine surgery and previous cesarean section. Menstrual history: Regularity, duration, amount, LMP. Contraceptive history: Previous used methods, any complications from any used method.
Obstetric history: Gravidity, parity, abortions, living, mode of delivery, date of the last delivery, gestational age and any obstetric complications.
Clinical examination:
General examination:
Assessment of patient general condition. vital data (pulse, blood pressure, temperature). Color of complexion e.g.: pallor in anemic patients.
Abdominal examination:
Inspection: globular abdomen, previous scar. Palpation: abdominal pain, tenderness, rigidity, uterine consistency, symphysio-fundal height (SFH) measurement, fetal lie, fetal presentation.
Auscultation: fetal heart sounds. Pelvic examination:Will not be done.
Ultrasound examination:
2D ultrasound will be carried out trans-abdominally to assess fetal viability and number, placental location, determine gestational age and fetal anomalies and calculate exact amniotic fluid index (AFI).
TVUS and placental bed Doppler will be done to confirm exact placental site and confirm diagnosis of placenta previa accreta according to RCOG criteria which are as follows) RCOG,2019):
2D greyscale signs: loss of myometrial interface or retroplacental clear space, reduced myometrial thickness, intra-placental blood flow and intra-placental lacunae.
2D color Doppler signs: intra-placental blood flow, the presence of altered blood flow in the retroplacental space and aberrant vessels crossing between placental surfaces.
All patients will be evaluated by ultrasonography examinations which will be performed at Ultrasound Special Care Unit Fetus, Ain Shams University Maternity Hospitals by ultrasound unit staff to confirm the gestational age, placental location. Lower placental edge thickness will be measured at the time of diagnosis using TVUS by the following technique. Visualization of lower placental edge will be done, while in the sagittal plane with the full length of the cervical canal and lower part of the uterus are in view. If the lower placental edge was not visualized, the transducer could be rotated 90° with the internal cervical os kept in view to detect the presence of placental tissue in the lower uterine cavity. Measurement of placental edge thickness of non-central placenta will be taken as the maximum measurement in the plane perpendicular to the long axis of the placenta, within 2cm of the lead point.
The thickness of the lower placental edge will be measured as the maximum thickness within a centimeter of the meeting point of the basal and chorionic plates. Thin placental edge will be considered when the thickness is <1cm. TVUS will be done at time of diagnosis to record measurement of lower placental edge thickness.
Follow-up of all cases and a scheduled elective cesarean section will be planned for all cases at completed 36 to 37 weeks of gestation following diagnosis of placental previa accreta by ultrasonography. Induction of fetal lung maturity will be carried out by giving 12 mg dexamethasone IM daily for two doses. If vaginal bleeding occurred prior to the scheduled cesarean section, patients will be admitted to the hospital and delivery will be decided in accordance with the clinical condition of the patient. Delivery will be performed at 36 completed weeks of gestation in cases of absent or mild vaginal bleeding. In cases of active bleeding that is clinically significant, or in those with massive APH, an emergency cesarean section will be done regardless of gestational age.
- Conditions
- Placenta Accreta
- Being tested
- 2D ultrasound
- Keywords
- Placental edge thickness, Placenta Accreta, Preterm delivery
- Medical subject headings
- Placenta Accreta, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D ultrasoundDevice
2D TVUS
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta.
Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta until delivery will occur.
Measured: Baseline
Secondary outcomes (6)
Type of cesarean delivery
elective versus emergency cesarean section <36 week of gestation due to massive hemorrhage
Measured: Baseline
Gestational age at delivery.
Gestational age at time of delivery.
Measured: Baseline
Antepartum bleeding, post-partum hemorrhage .
Antepartum bleeding, post-partum hemorrhage at the time of cesarean section.
Measured: Baseline
Need for Cesarean hysterectomy
Need for Cesarean hysterectomy at time of delivery
Measured: Baseline
Peripartum blood transfusion
Peripartum blood transfusion at time of delivery
Measured: Baseline
Neonatal birth weight.
Neonatal birth weight at time of delivery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start12 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif Fathi, MD, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248385
- Sponsor's protocol ID
- TVS in placenta accreta
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Syed W, Liaqat N, Naseeb G, Khattak SM. Relationship of placental edge thickness and cervical length to gestational age at delivery in patients with placenta previa. Pak J Med Sci. 2022 May-Jun;38(5):1349-1352. doi: 10.12669/pjms.38.5.5097.
PubMed 35799721Zaitoun MM, El Behery MM, Abd El Hameed AA, Soliman BS. Does cervical length and the lower placental edge thickness measurement correlates with clinical outcome in cases of complete placenta previa? Arch Gynecol Obstet. 2011 Oct;284(4):867-73. doi: 10.1007/s00404-010-1737-1. Epub 2010 Nov 27.
PubMed 21113721Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
PubMed 30260097
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of the Lower Placental Edge Thickness in Relation to Gestational Age at Delivery by Using Ultrasonography in Patients With Placenta Previa Accreta; A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06248385
- Acronym / sponsor ID
- TVS in placenta accreta
- Conditions
- Placenta Accreta
- Keywords
- Placental edge thickness, Placenta Accreta, Preterm delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Feb 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.
The aim of our study is to determine correlation between lower placental edge thickness measured by ultrasound and gestational age at delivery and predict the risk of emergency preterm birth in patients having placenta previa accreta.
Detailed description
In pregnant women with placenta previa accreta, the lower placental edge thickness measured by ultrasound may correlate with gestational age at delivery and predict emergency preterm cesarean delivery. Thick lower placental edge is thought to be responsible for emergency preterm birth.
All women who meet the inclusion criteria will undergo full assessment to identify eligible women.
This assessment will include:
Detailed History:Personal history: age, duration of marriage, smoking. Present history: any current medical or surgical diseases and current medication.
Past medical history: history of medical disorders like diabetes and hypertension.
Surgical history: previous uterine surgery and previous cesarean section. Menstrual history: Regularity, duration, amount, LMP. Contraceptive history: Previous used methods, any complications from any used method.
Obstetric history: Gravidity, parity, abortions, living, mode of delivery, date of the last delivery, gestational age and any obstetric complications.
Clinical examination:
General examination:
Assessment of patient general condition. vital data (pulse, blood pressure, temperature). Color of complexion e.g.: pallor in anemic patients.
Abdominal examination:
Inspection: globular abdomen, previous scar. Palpation: abdominal pain, tenderness, rigidity, uterine consistency, symphysio-fundal height (SFH) measurement, fetal lie, fetal presentation.
Auscultation: fetal heart sounds. Pelvic examination:Will not be done.
Ultrasound examination:
2D ultrasound will be carried out trans-abdominally to assess fetal viability and number, placental location, determine gestational age and fetal anomalies and calculate exact amniotic fluid index (AFI).
TVUS and placental bed Doppler will be done to confirm exact placental site and confirm diagnosis of placenta previa accreta according to RCOG criteria which are as follows) RCOG,2019):
2D greyscale signs: loss of myometrial interface or retroplacental clear space, reduced myometrial thickness, intra-placental blood flow and intra-placental lacunae.
2D color Doppler signs: intra-placental blood flow, the presence of altered blood flow in the retroplacental space and aberrant vessels crossing between placental surfaces.
All patients will be evaluated by ultrasonography examinations which will be performed at Ultrasound Special Care Unit Fetus, Ain Shams University Maternity Hospitals by ultrasound unit staff to confirm the gestational age, placental location. Lower placental edge thickness will be measured at the time of diagnosis using TVUS by the following technique. Visualization of lower placental edge will be done, while in the sagittal plane with the full length of the cervical canal and lower part of the uterus are in view. If the lower placental edge was not visualized, the transducer could be rotated 90° with the internal cervical os kept in view to detect the presence of placental tissue in the lower uterine cavity. Measurement of placental edge thickness of non-central placenta will be taken as the maximum measurement in the plane perpendicular to the long axis of the placenta, within 2cm of the lead point.
The thickness of the lower placental edge will be measured as the maximum thickness within a centimeter of the meeting point of the basal and chorionic plates. Thin placental edge will be considered when the thickness is <1cm. TVUS will be done at time of diagnosis to record measurement of lower placental edge thickness.
Follow-up of all cases and a scheduled elective cesarean section will be planned for all cases at completed 36 to 37 weeks of gestation following diagnosis of placental previa accreta by ultrasonography. Induction of fetal lung maturity will be carried out by giving 12 mg dexamethasone IM daily for two doses. If vaginal bleeding occurred prior to the scheduled cesarean section, patients will be admitted to the hospital and delivery will be decided in accordance with the clinical condition of the patient. Delivery will be performed at 36 completed weeks of gestation in cases of absent or mild vaginal bleeding. In cases of active bleeding that is clinically significant, or in those with massive APH, an emergency cesarean section will be done regardless of gestational age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study will be carried out on 50 women with a singleton pregnancy, between 28-36 weeks, with placenta previa accreta by suspected sonographic examination.
Key inclusion criteria (5 listed)
- Single, viable gestations. Gestational age >28 weeks, < 36 weeks.
- Confirmed diagnosis of placenta previa accreta when the placenta lies directly over the internal os based on ultrasound features among RCOG criteria as follows) RCOG,2019):
- 2D greyscale signs: loss of myometrial interface or retroplacental clear space, reduced myometrial thickness, intra-placental blood flow and intra-placental lacunae.
- 2D color Doppler signs: intra-placental blood flow, the presence of altered blood flow in the retroplacental space and aberrant vessels crossing between placental surfaces.
- First time of diagnosis of placenta previa accreta is 28-30 weeks. Previous one or more cesarean sections.
Key exclusion criteria (3 listed)
- Maternal medical co-morbidities like diabetes and hypertension. Patients with bleeding disorders or anticoagulant therapy. Over distended uterus e.g.: multiple gestation, polyhydramnios, fetal macrosomia(>4.5kg).
- Fetal anomalies or fetal growth restriction. Emergency cesarean section due to fetal distress. Rupture of membranes, intra-amniotic infection and fever during admission (>38 °C).
- History of cervical cerclage or cervical cone biopsy.
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 |
|---|---|---|
| 2D ultrasound2D TVUS | Device | – |
Primary outcome
Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta.
Time frame: Baseline
Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta until delivery will occur.
6 secondary outcomes
Type of cesarean delivery
Time frame: Baseline
Gestational age at delivery.
Time frame: Baseline
Antepartum bleeding, post-partum hemorrhage .
Time frame: Baseline
Need for Cesarean hysterectomy
Time frame: Baseline
Peripartum blood transfusion
Time frame: Baseline
Neonatal birth weight.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 35799721Syed W, Liaqat N, Naseeb G, Khattak SM. Relationship of placental edge thickness and cervical length to gestational age at delivery in patients with placenta previa. Pak J Med Sci. 2022 May-Jun;38(5):1349-1352. doi: 10.12669/pjms.38.5.5097.
- Background: PubMed 21113721Zaitoun MM, El Behery MM, Abd El Hameed AA, Soliman BS. Does cervical length and the lower placental edge thickness measurement correlates with clinical outcome in cases of complete placenta previa? Arch Gynecol Obstet. 2011 Oct;284(4):867-73. doi: 10.1007/s00404-010-1737-1. Epub 2010 Nov 27.
- Background: PubMed 30260097Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
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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.
Alaa Said, MD contact
Sherif Fathi, MD study director
World Health Organization
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 Accreta, run by Ain Shams 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 3 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 6 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba Eid, M.Sc. (+201069395117, hebaeid2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06248385, which also lists 3 linked publications.
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 6 Aug 2024.