Trials / Completed
CompletedNCT04911322
Pulmonary Artery Doppler and Neonatal Outcome in Placenta Accreta Spectrum Patients
Correlation Between Pulmonary Artery Doppler And Other Ultrasonographic Markers With Neonatal Outcome In Placenta Accreta Spectrum Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 71 (actual)
- Sponsor
- Cairo University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 42 Years
- Healthy volunteers
- —
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ultrasonography | 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. |
Timeline
- Start date
- 2021-08-15
- Primary completion
- 2022-08-01
- Completion
- 2022-09-01
- First posted
- 2021-06-03
- Last updated
- 2022-09-07
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04911322. Inclusion in this directory is not an endorsement.