3D Ultrasonography Fetal Lung Volume Measurement and Neonatal Respiratory Function

NCT02475811 | Completed DMC

• 1 other identifier: 137
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred healthy women with singleton pregnancies in the 1st stage of labor will be included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks). A 3D volume model of the right fetal lung is generated \& lung volume is calculated using VOCAL software. After child birth, neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min) together with occurrence of RDS and the further need for NICU admission and respiratory support measurements.

Conditions

Neonatal Respiratory Function

Keywords

3D ultrasonography; fetal Lung Volume; neonatal respiratory function

Outcome Measures

Primary Outcomes (1)

• Apgar score

  1 minute after delivery

Secondary Outcomes (2)

• Neonatal ICU admission

  24 hour after delivery

• Apgar score

  5 minutes after delivery

Interventions

3D ultrasonography RADIATION

The angle of volume sampling varied throughout gestational age with a maximum limit of 75° in the third trimester. After scanning the volume, multiplanar imaging in the 3 orthogonal ultrasonographic sections was analyzed to reconstruct the 3D ultrasound image. Before its volume was analyzed, each lung was carefully identified on the 3 orthogonal multiplanar imaging sections. We used the rotational technique that entails the VOCAL imaging program to measure lung volume. A transverse section of the multiplanar imaging was chosen as the reference image for volume analyses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

One hundred healthy women with singleton pregnancies presented in the 1st stage of labour

You may qualify if:

• One hundred healthy women with singleton pregnancies presented in the 1st stage of labour were included in the study. Participants were divided into two groups; Group A (n: 50 - women pregnant ± 34-37 weeks gestation) \& Group B (n: 50 - women pregnant ± 37+1-40 weeks gestation). Gestational age (GA) is established by menstrual dates then confirmed by obstetric ultrasound

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

Study Officials

• Ahmed Maged

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

EG (1)