Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity
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|ClinicalTrials.gov Identifier: NCT02331199|
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was: Recruiting
First Posted : January 6, 2015
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labour||Device: Amniotic fluid lamellar body count Device: Fetal pulmonary artery Doppler||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2017|
Experimental: preterm labour
200 women with preterm prelabour ruptured membranes or undergoing preterm CS
Device: Amniotic fluid lamellar body count
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.
Other Name: Amniotic fluid lamellar body count will be measured
Device: Fetal pulmonary artery Doppler
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) [ Time Frame: 1 day after delivery ]RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.
- Need for incubation [ Time Frame: 1 day after delivery ]It will be recorded if the pediatrician decides to incubate the neonate. The reason for incubation e.g. ventilation, hypoxia, ischemia will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331199
|Contact: AbdelGany MA Hassan, MRCOG, MDfirstname.lastname@example.org|
|Al Galaa maternity fospital||Recruiting|
|Contact: Mohamed Wafeek 002 01223524286|
|Principal Investigator: Mohamed Wafeek|
|Cairo university hospitals||Recruiting|
|Contact: AbdelGany Hassan, MRCOG, MD 002 01017801604 email@example.com|
|Sub-Investigator: AbdelGany MA Hassan, MRCOG, MD|
|Principal Investigator: Sherif Negm, MD|
|Sub-Investigator: Doaa Salah, MD|