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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02475811 |
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Date of registration:
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15/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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3D Ultrasonography Fetal Lung Volume Measurement and Neonatal Respiratory Function
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Scientific title:
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The Role of 3D Ultrasonography Fetal Lung Volume Measurement in the Prediction of Neonatal Respiratory Function Outcome |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02475811 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed Maged |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kasr Alainy medical school |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Exclusion criteria include the maternal administration of respiratory depressants
within 2 hours from the delivery of the fetus (e. g., opioid analgesic & general
anesthesia upon doing CS) or oligohydramnios (amniotic fluid index < 5th centile),
rupture of membranes, the presence of fetal malformations (chest, heart or abdominal)
or abnormal fetal growth (defined as: estimated fetal weight < 5th centile or > 95th
centile and/or abdominal circumference < 5th centile or > 95th centile). Also, women
with a cardiac pacemaker were excluded (as the transmitter necessary for the lung
volume measurements could disturb the function of the pacemaker).
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neonatal Respiratory Function
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Intervention(s)
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Radiation: 3D ultrasonography
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Primary Outcome(s)
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Apgar score
[Time Frame: 1 minute after delivery]
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Secondary Outcome(s)
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Apgar score
[Time Frame: 5 minutes after delivery]
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Neonatal ICU admission
[Time Frame: 24 hour after delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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