An observational study in Placenta Accreta, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Ain Shams University · Observational
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.
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.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 50 is below the median of 87 across 78 observational studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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 .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2D TVUS
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.
Time frame: Baseline
Type of cesarean delivery
elective versus emergency cesarean section \<36 week of gestation due to massive hemorrhage
Time frame: Baseline
Gestational age at delivery.
Gestational age at time of delivery.
Time frame: Baseline
Antepartum bleeding, post-partum hemorrhage .
Antepartum bleeding, post-partum hemorrhage at the time of cesarean section.
Time frame: Baseline
Need for Cesarean hysterectomy
Need for Cesarean hysterectomy at time of delivery
Time frame: Baseline
Peripartum blood transfusion
Peripartum blood transfusion at time of delivery
Time frame: Baseline
Neonatal birth weight.
Neonatal birth weight at time of delivery
Time frame: Baseline
Started Feb 2024 (actual). Primary completion is estimated for Feb 2025, 12 months after the start.
Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.