Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248385
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Lower Placental Edge Thickness in Relation to Gestational Age at Delivery in Placenta Accreta Prospective Cohort Study
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 HistoryPersonal 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 eg 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 examinationWill 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 RCOG2019
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
All women who meet the inclusion criteria will undergo full assessment to identify eligible women
This assessment will include
Detailed HistoryPersonal 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 eg 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 examinationWill 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 RCOG2019
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None