Prediction of Fetal Lung Maturity

Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers

Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.

Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.

Study Overview

• Status: Completed
• Conditions: Fetal Distress
• Intervention / Treatment: Radiation: fetal lung volume; Radiation: pulmonary artery resistance index; Radiation: Fetal adrenal gland volume:

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

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:

• All pregnant diabetic women
• 37 weeks gestational age .

Exclusion Criteria:

• Women before 37 and after 39 weeks gestational age
• Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
• Multiple pregnancies.
• Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
• Women with premature rupture of membranes (prom)
• Pregnancies complicated by medical disorders other than diabetes mellitus .
• Failure to obtain an informed consent .

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

Other: Diabetic pregnant women

Radiation: fetal lung volume; the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia; Radiation: pulmonary artery resistance index; Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery; Radiation: Fetal adrenal gland volume: the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
APGAR score	5 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fetal Distress; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 17100188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No