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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Ain Shams University Maternity Hospitals

    Cairo

    Rehab Abdel Rahman

    Recruiting

Other trials in Egypt

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.

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.

  1. 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)
  1. Type of cesarean delivery

    elective versus emergency cesarean section <36 week of gestation due to massive hemorrhage

    Measured: Baseline

  2. Gestational age at delivery.

    Gestational age at time of delivery.

    Measured: Baseline

  3. Antepartum bleeding, post-partum hemorrhage .

    Antepartum bleeding, post-partum hemorrhage at the time of cesarean section.

    Measured: Baseline

  4. Need for Cesarean hysterectomy

    Need for Cesarean hysterectomy at time of delivery

    Measured: Baseline

  5. Peripartum blood transfusion

    Peripartum blood transfusion at time of delivery

    Measured: Baseline

  6. 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.

  1. First posted8 Feb 2024
  2. Study start12 Feb 2024
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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)
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 35799721
  • Zaitoun 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 21113721
  • Jauniaux 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

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.

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