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Clinical Trials/NCT02331199
NCT02331199UnknownPhase 3

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

Cairo University2 sites in 1 country200 target enrollmentStarted: December 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Enrollment
200
Locations
2
Primary Endpoint
Respiratory distress syndrome (RDS)

Study Overview

Brief 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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

preterm labour

Experimental

200 women with preterm prelabour ruptured membranes or undergoing preterm CS

Intervention: Amniotic fluid lamellar body count (Device)

preterm labour

Experimental

200 women with preterm prelabour ruptured membranes or undergoing preterm CS

Intervention: Fetal pulmonary artery Doppler (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Need for incubation(1 day after delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

Study Sites (2)

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