An observational study in Placenta Accreta, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Cairo University · Observational
To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.
The increasing rates of cesarean section has led to several fold increase in the incidence of placenta accreta spectrum in the last three or four decades.
Placenta accreta spectrum (PAS) disorders is the term used to describe a variety of pregnancy complications resulting from abnormal placental implantation that is accompanied by deficiency of the uterine wall.
Placenta accreta spectrum includes placenta accreta, placenta increta, placenta percreta.
Placenta accreta spectrum is one of the devastating obstetric complications owing to massive hemorrhage encountered during manual removal of the placenta to preserve the uterus or even the need for peripartum hysterectomy, need for massive blood transfusion, maternal intensive care admission and maternal mortality.
Complications related to blood loss are lower in elective compared to emergency deliveries. This has led to the scheduling of surgical interventions with planned late preterm (35-36 weeks) or early term (37 weeks) delivery as a mechanism to avoid the need for emergency surgery. According to the RCOG guidelines, planned delivery at 35 0/7- 36 0/7 weeks of gestation provides the best chance between fetal maturity and the risk of unscheduled delivery while ACOG recommends 34 0/7- 35 6/7.
Early attempts have been made to predict fetal maturity on the basis antenatal sonographic parameters including lung characteristics, bowel pattern, placental grading (which cannot be relied upon in patients with placenta accreta spectrum), and the presence or absence of intraamniotic particles (vernix caseosa).
Additionally, the epiphyseal ossification centers appear and enlarge at variable rates but in a predictable sequence: the distal femoral epiphysis (DFE) appears prior to the proximal tibial epiphysis (PTE), which precedes the appearance of the proximal humeral epiphysis (PHE). The PTE grows more rapidly than does the DFE so that, as gestation progresses, the size of the PTE approaches that of the DFE.
More recently, fetal pulmonary artery Doppler has been used to predict neonatal RDS. It was found that an elevated acceleration-to-ejection time ratio was significantly associated with neonatal RDS. However such indices cannot be generalized in all cases, especially those with placenta accreta spectrum who have excessive placental shunting affecting fetoplacental circulation resistance.
To the best of our knowledge, no available studies have correlated signs of maturity of the fetus detected by ultrasound with neonatal outcomes in the late preterm and early term in such patients. Presence of such signs of maturity can aid the obstetrician to choose the most appropriate timing for termination especially in low income countries who have limited access to NICUs.
Being cost effective and non invasive, ultrasonography is used as a routine obstetric scanning tool. This study will help determine the utility of ultrasound in assessing the fetal lung maturity in such patients.
147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.
This study's enrollment of 71 is below the median of 84 across 79 observational studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with placenta accreta spectrum with singleton pregnancy undergoing cesarean delivery in Kasr Alainy hospital.
Exclusion Criteria:
A full obstetric ultrasound scan will be performed to assess signs of placental invasion, to document fetal biometry, estimated fetal weight, amniotic fluid index, assess fetal lung maturity parameters as pulmonary artery Doppler waveforms, amniotic fluid free floating particles, bowel echogenicity, fetal epiphyseal ossific centers, liver/lung echogenicity and kidney length. Pulmonary artery Doppler: Fetal echocardiography will be done. Pulmonary artery Doppler flow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time ratio will be measured in the main pulmonary artery.
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.
(At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome
Time frame: Baseline
The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.
The PI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Time frame: Baseline
The resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
RI will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Time frame: Baseline
The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
S/D will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Time frame: Baseline
The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome
PSV will be measured in the fetal main pulmonary artery and will be correlated with the neonatal outcome
Time frame: Baseline
Optimal timing of delivery in PAS for best neonatal outcome
according to the neonatal outcome, the best timing for delivery will be determined
Time frame: baseline
Optimal timing of delivery in PAS for best maternal outcome
according to the maternal mortality and morbidity rate, the best timing for delivery will be obtained
Time frame: baseline
percent of women who will undergo cesarean hysterectomy versus conservative management
surgical management options; cesarean hysterectomy and conservative management will be recorded
Time frame: baseline
The need for blood transfusion
The need for replacement by blood or blood products will be recorded
Time frame: baseline
Maternal morbidity in the form of organ injury will be recorded
Organ injury will be recorded
Time frame: baseline
The need for peripartum hysterectomy will be recorded
The need for peripartum hysterectomy either in cases of abnormally invasive placenta or in cases of abnormally adherent placenta in which the placenta separated but with uncontrollable bleeding
Time frame: Baseline
Maternal mortality rate
Rate of maternal mortality will be recorded
Time frame: Baseline
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Cairo University