Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing

Not Applicable

Completed

• Conditions: Umbilical Artery Doppler; Fetal Heart Rate Tracing
• Interventions: Radiation: mobile phone

• Registration Number: NCT02445261
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Study Start: 2015-06-01
• Primary Completion: 2017-12-02
• Status Verified: 2018-01
• Study Completion: 2018-01-23
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
normal growth	mobile phone	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
growth restricted group	mobile phone	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

Primary Outcome Measures

Name	Time	Method
umbilical artery doppler	5 minutes after hanging up the mobile phone

Secondary Outcome Measures

Name	Time	Method
fetal heart rate tracing	10 minutes after phone is in the dialing mode for

Trial Locations

Locations (2)

Ahmed Maged; 🇪🇬 Cairo, Egypt

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt