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

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

Study Overview

• Status: Unknown
• Conditions: Preterm Labour
• Intervention / Treatment: Device: Amniotic fluid lamellar body count; Device: Fetal pulmonary artery Doppler

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AbdelGany MA Hassan, MRCOG, MD; Phone Number: +201017801604; Email: abdelgany2@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals
    • Contact: AbdelGany Hassan, MRCOG, MD; Phone Number: 002 01017801604; Email: abdelgany2@gmail.com
    • Sub-Investigator: AbdelGany MA Hassan, MRCOG, MD
    • Principal Investigator: Sherif Negm, MD
    • Sub-Investigator: Doaa Salah, MD
  • Cairo, Egypt
    • Recruiting
    • Al Galaa maternity fospital
    • Contact: Mohamed Wafeek; Phone Number: 002 01223524286
    • Principal Investigator: Mohamed Wafeek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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. doi: 10.1001/archpedi.1959.02070010519001. No abstract available.
• 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.
• 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. doi: 10.1016/s0029-7844(00)01134-0.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 31, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: preterm 1