NCT02445261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

May 11, 2015

Last Update Submit

January 23, 2018

Conditions

Umbilical Artery DopplerFetal Heart Rate Tracing

Keywords

MOBILE PHONE ON AND IN ANDUMBILICAL ARTERY DOPPLERFETAL CARDIOTOCOGRAPHYGROWTH RESTRICTED FETUSNORMAL GROWTH FETUS

Outcome Measures

Primary Outcomes (1)

  • umbilical artery doppler

    5 minutes after hanging up the mobile phone

Secondary Outcomes (1)

  • fetal heart rate tracing

    10 minutes after phone is in the dialing mode for

Study Arms (2)

normal growth

ACTIVE COMPARATOR

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

Radiation: mobile phone

growth restricted group

ACTIVE COMPARATOR

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

Radiation: mobile phone

Interventions

mobile phoneRADIATION

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.

growth restricted groupnormal growth

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18 to 40 years pregnant between
  • singleton fetus
  • 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.

You may not qualify if:

  • presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Maged

Cairo, 12151, Egypt

Location

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Study Officials

  • Ahmed M Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 15, 2015

Study Start

June 1, 2015

Primary Completion

December 2, 2017

Study Completion

January 23, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

EG(2)