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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
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

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

Condition or disease Intervention/treatment Phase
Preterm Labour Device: Amniotic fluid lamellar body count Device: Fetal pulmonary artery Doppler Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: AbdelGany MA Hassan, MRCOG, MD +201017801604 abdelgany2@gmail.com

Locations
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Egypt
Al Galaa maternity fospital Recruiting
Cairo, Egypt
Contact: Mohamed Wafeek    002 01223524286      
Principal Investigator: Mohamed Wafeek         
Cairo university hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany Hassan, MRCOG, MD    002 01017801604    abdelgany2@gmail.com   
Sub-Investigator: AbdelGany MA Hassan, MRCOG, MD         
Principal Investigator: Sherif Negm, MD         
Sub-Investigator: Doaa Salah, MD         
Sponsors and Collaborators
Cairo University
Publications:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02331199    
Other Study ID Numbers: preterm 1
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications