- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445261
Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing
January 23, 2018 updated by: Ahmed Maged, Cairo University
The Effects of Mobile Phone on Umbilical Artery Doppler and Fetal Cardiotogogrphy in Normal and Gowth Restricted Fetuses
Women were instructed not to use the mobile phones for 24 hours before carrying out the initial CTG trace and Doppler ultrasound.
For each patient, initial 15 minutes CTG trace recording was done followed by umbilical artery Doppler ultrasound using high resolution ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic a200 City country).
Thereafter, the mobile phone (type, in the dialing mode, was put on the mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace.
The umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference with the Doppler machine.
The umbilical artery Doppler ultrasound and the recorded fetal heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of spontaneous decelerations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 12151
- Kasr Alainy medical school
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Cairo, Egypt, 12151
- Ahmed Maged
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- aged 18 to 40 years pregnant between
- singleton fetus
- 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120 women with normally growing fetuses. Group (B) included 70 women with growth-restricted fetuses.
Exclusion Criteria:
- presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: normal growth
120 woman with normal fetal growth will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes.
Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations were assessed
|
Each woman was subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes.
Umbilical artery (UA) Doppler ultrasound was done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
|
Active Comparator: growth restricted group
70 woman with l growth restricted fetus will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes.
Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations
|
Each woman was subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes.
Umbilical artery (UA) Doppler ultrasound was done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
umbilical artery doppler
Time Frame: 5 minutes after hanging up the mobile phone
|
5 minutes after hanging up the mobile phone
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fetal heart rate tracing
Time Frame: 10 minutes after phone is in the dialing mode for
|
10 minutes after phone is in the dialing mode for
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed M Maged, Kasr Alainy medical school
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
December 2, 2017
Study Completion (Actual)
January 23, 2018
Study Registration Dates
First Submitted
May 11, 2015
First Submitted That Met QC Criteria
May 12, 2015
First Posted (Estimate)
May 15, 2015
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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