Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity

Preterm Labour Clinical Trial

Official title:

Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331199
• Other study ID #: preterm 1
• Status: Recruiting
• Phase: Phase 3
• First received: December 31, 2014
• Last updated: January 20, 2017
• Start date: December 2014

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: AbdelGany MA Hassan, MRCOG, MD
• Phone: +201017801604
• Email: abdelgany2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancies without any major congenital anomalies.

• Gestation between 32-36 weeks

• Women presenting preterm pre-labour ruptured membranes or undergoing a cesarean section.

Exclusion Criteria:

• Patients with major fetal anomalies.

• Bloody or meconium stained amniotic fluid

• preexisting maternal medical conditions (eg, diabetes, renal disease, hypertensive disorders, vaginal bleeding

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labour

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Al Galaa maternity fospital	Cairo
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

AVERY ME, MEAD J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959 May;97(5, Part 1):517-23. — View Citation

Dubin SB. Characterization of amniotic fluid lamellar bodies by resistive-pulse counting: relationship to measures of fetal lung maturity. Clin Chem. 1989 Apr;35(4):612-6. — View Citation

Neerhof MG, Dohnal JC, Ashwood ER, Lee IS, Anceschi MM. Lamellar body counts: a consensus on protocol. Obstet Gynecol. 2001 Feb;97(2):318-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory distress syndrome (RDS)	RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.	1 day after delivery
Secondary	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.	1 day after delivery