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

Primary Purpose

Preterm Labour

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Amniotic fluid lamellar body count
Fetal pulmonary artery Doppler
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Labour

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Al Galaa maternity fospitalRecruiting
  • Cairo university hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preterm labour

Arm Description

200 women with preterm prelabour ruptured membranes or undergoing preterm CS

Outcomes

Primary Outcome Measures

Respiratory distress syndrome (RDS)
RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.

Secondary Outcome Measures

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.

Full Information

First Posted
December 31, 2014
Last Updated
January 20, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02331199
Brief Title
Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity
Official Title
Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labour

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preterm labour
Arm Type
Experimental
Arm Description
200 women with preterm prelabour ruptured membranes or undergoing preterm CS
Intervention Type
Device
Intervention Name(s)
Amniotic fluid lamellar body count
Other Intervention Name(s)
Amniotic fluid lamellar body count will be measured
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fetal pulmonary artery Doppler
Intervention Description
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 Measure Information:
Title
Respiratory distress syndrome (RDS)
Description
RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.
Time Frame
1 day after delivery
Secondary Outcome Measure Information:
Title
Need for incubation
Description
It will be recorded if the pediatrician decides to incubate the neonate. The reason for incubation e.g. ventilation, hypoxia, ischemia will be recorded.
Time Frame
1 day after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AbdelGany MA Hassan, MRCOG, MD
Phone
+201017801604
Email
abdelgany2@gmail.com
Facility Information:
Facility Name
Al Galaa maternity fospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Wafeek
Phone
002 01223524286
First Name & Middle Initial & Last Name & Degree
Mohamed Wafeek
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AbdelGany Hassan, MRCOG, MD
Phone
002 01017801604
Email
abdelgany2@gmail.com
First Name & Middle Initial & Last Name & Degree
AbdelGany MA Hassan, MRCOG, MD
First Name & Middle Initial & Last Name & Degree
Sherif Negm, MD
First Name & Middle Initial & Last Name & Degree
Doaa Salah, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
13649082
Citation
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.
Results Reference
background
PubMed Identifier
2702746
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.
Results Reference
background
PubMed Identifier
11165603
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. doi: 10.1016/s0029-7844(00)01134-0.
Results Reference
background

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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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