A Phase 3 interventional study of Amniotic fluid lamellar body count and Fetal pulmonary artery Doppler in Preterm Labour, sponsored by Cairo University. Status unknown at 2 sites in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by Cairo University · Phase 3, Interventional, and Diagnostic
The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome
Neonatal respiratory distress syndrome (RDS) remains a major cause of neonatal morbidity and mortality. A recent epidemiologic study in the United States estimates that there are 80,000 cases of neonatal RDS each year, resulting in 8500 deaths and hospital costs in excess of $4.4 billion.
A number of biochemical tests have been developed to predict the risk of RDS and assist obstetric care providers in delivery timing. Amniotic fluid lamellar body count (LBC) is an important biophysical test, based on measuring the concentration of pulmonary surfactant in amniotic fluid. It can be effectively used to assess fetal lung maturity. A noninvasive test for fetal lung maturity (FLM) would be useful to minimize the need for invasive testing and would be more acceptable to women. Fetal pulmonary artery Doppler waveform acceleration/ejection time may provide a noninvasive means of determining fetal lung maturity with relatively acceptable levels of sensitivity, specificity, and predictive values.
The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome.
Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using Mann Whitney U test for independent samples while categorical data will compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.
255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.
This study's planned enrollment of 200 is above the median of 110 across 155 interventional studies indexed under Obstetric Labor, Premature.
Browse Obstetric Labor, Premature 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.
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Exclusion Criteria:
200 women with preterm prelabour ruptured membranes or undergoing preterm CS
Device: Amniotic fluid lamellar body count · Device: Fetal pulmonary artery Doppler
The LBC (the unit of measurement is number of lamellar bodies counted per microliter of amniotic fluid) will be determined using the platelet channels on the Hematology Flow Cytometer.
Also known as: Amniotic fluid lamellar body count will be measured
A fetal pulmonary artery Doppler will be performed using color Doppler ultrasound. Doppler flow velocity measurements, including systolic/diastolic ratio, pulsatility index, resistance index, and acceleration-time/ejection-time ratio using spectral Doppler ultrasound.
Respiratory distress syndrome (RDS)
RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.
Time frame: 1 day after delivery
Need for incubation
It will be recorded if the pediatrician decides to incubate the neonate. The reason for incubation e.g. ventilation, hypoxia, ischemia will be recorded.
Time frame: 1 day after delivery
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Cairo University