NCT07271680

Brief Summary

This prospective cohort study investigates the relationship between smartphone addiction and fetal health parameters at the third trimester of pregnancy. Pregnant women will be evaluated for smartphone addiction, and fetal heart rate, uterine artery blood flow indices (Resistive Index, Systolic/Diastolic ratio), and birth weight will be measured. The hypothesis is that smartphone addiction may negatively affect fetal outcomes, leading to higher fetal heart rate, impaired uterine artery blood flow, and lower birth weight. Although no direct studies have examined smartphone addiction and these fetal parameters together, related evidence suggests possible adverse effects of mobile phone exposure on oxidative stress, infant birth weight, fetal heart rate variability, and anthropometric measures. This study is among the first to specifically link smartphone addiction with maternal-fetal outcomes, offering new insights into environmental risk factors during late pregnancy. The findings aim to provide healthcare professionals with evidence based guidance for counseling pregnant women on safe smartphone use to protect maternal and fetal health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

September 4, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

pregnancyuterine blood flowfetal heart ratebirth weightsmart phone addiction

Outcome Measures

Primary Outcomes (3)

  • Fetal Heart Rate Measurement

    Fetal heart rate will be measured using ultrasound. Measurements will be performed by an experienced obstetrician and gynecologist in accordance with standard protocols.

    At baseline visit (single ultrasound assessment on the day of enrollment)

  • Resistance Index Measurement

    RI will be checked and noted. obtained data will be compared with reference data for the given gestational age, and uterine blood flow will be coded as 0 for decreased and 1 for normal.

    At baseline visit (single Doppler assessment on the day of enrollment)

  • Systolic/ Diastolic Ratio Measurement

    S/D ratio will be checked and noted. The obtained data will be compared with reference data for the given gestational age, and uterine blood flow will be coded as 0 for decreased and 1 for normal.

    At baseline visit (single Doppler assessment on the day of enrollment)

Secondary Outcomes (1)

  • Birth weight measurement

    At delivery (from enrollment until birth, assessed once at the time of delivery, up to approximately 12 weeks after enrollment)

Study Arms (2)

Pregnant women with smartphone addiction

According to Smartphone Addiction Scale - Short Version (SAS-SV) pregnant women with a score of 33 or higher (accepted as addicted to their smartphones according to the scale).

Pregnant women without smartphone addiction

According to SAS-SV pregnant women with a score of 32 or lower (accepted as not addicted to their smartphones according to the scale).

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population will consist of pregnant women in their third trimester (34-36 weeks of gestation) who present to Obstetric Clinics for routine antenatal follow-up. Eligible participants are biological females, aged 18-40 years, with singleton pregnancies, smartphone users, and without chronic systemic disease, fetal anomalies, or other exclusion criteria.

You may qualify if:

  • Clinical diagnosis of singleton pregnancy
  • Must be in the third trimester of pregnancy (confirmed by ultrasound)
  • Must agree to participate voluntarily in the study and signing the informed consent form
  • Must own a smartphone

You may not qualify if:

  • Clinical diagnosis of multiple pregnancy
  • History of miscarriage in previous pregnancies (3 or more)
  • Clinical diagnosis of chronic systemic diseases (e.g., diabetes, hypertension, thyroid disease)
  • Clinical diagnosis of fetal anomaly in the fetus
  • Drug or substance addiction
  • Clinical diagnosis of serious psychiatric disorder
  • Cigarette smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ministry of Health Antalya City Hospital

Antalya, 07080, Turkey (Türkiye)

Location

Antalya Anatolia Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (3)

  • Kwon M, Kim DJ, Cho H, Yang S. The smartphone addiction scale: development and validation of a short version for adolescents. PLoS One. 2013 Dec 31;8(12):e83558. doi: 10.1371/journal.pone.0083558. eCollection 2013.

    PMID: 24391787BACKGROUND
  • Lu X, Oda M, Ohba T, Mitsubuchi H, Masuda S, Katoh T. Association of excessive mobile phone use during pregnancy with birth weight: an adjunct study in Kumamoto of Japan Environment and Children's Study. Environ Health Prev Med. 2017 Jun 8;22(1):52. doi: 10.1186/s12199-017-0656-1.

    PMID: 29165149BACKGROUND
  • Özen G, Kahvecioğlu D, Bulut İ, Erel Ö, Neşelioğlu S, Üstün Y, Taşar MA. Effect of Mobile Phone Usage During Pregnancy on Total Oxidant and Antioxidant Levels in Cord Blood. J Behcet Uz Child Hosp 2023;13(3):177-184.

    BACKGROUND

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Selkin Yilmaz Muluk, MD

    Ministry of Health Antalya City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2025

First Posted

December 9, 2025

Study Start

August 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 15, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available to researchers who provide a methodologically sound and ethically approved research proposal. Data will be shared via a secure, designated platform, and a data use agreement will be required to ensure compliance with privacy and ethical standards.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
5 years
Access Criteria
De-identified individual participant data will be made available to researchers who provide a methodologically sound and ethically approved research proposal. Data will be shared via a secure, designated platform, and a data use agreement will be required to ensure compliance with privacy and ethical standards.
More information

Locations