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A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns

A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03655379
Enrollment
73
Registered
2018-08-31
Start date
2018-01-01
Completion date
2019-07-01
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Preterm birth, Fetal nasal Doppler, Fetal breathing

Brief summary

Preterm birth refers to a delivery that occurs before 37 weeks of gestation. Identification of those who will eventually deliver in the preterm period is very important. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

Detailed description

Preterm birth refers to a delivery that occurs before 37 weeks of gestation and it is the leading cause of neonatal morbidity and mortality. 33% of prenatal hospital admissions are due to preterm labor but almost 50% of patients receiving tocolytics in order to prevent birth deliver in the term period. Therefore, identification of those who will eventually deliver in the preterm period is very important. Ideally, identification of modifiable and nonmodifiable risk factors for preterm birth in will lead to interventions that help prevent this complication. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. Another method for preterm birth prediction is presence of fetal breathing. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

Interventions

DEVICEFetal nasal Doppler by ultrasonography

Pregnant patients who present with preterm labor will be evaluated with ultrasonography and fetal nasal Doppler will be used to detect specific fetal breathing patterns and measurements will be performed

Sponsors

Batman Maternity Hospital
CollaboratorUNKNOWN
Baskent University Ankara Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Pregnant patients between 24-37 gestational weeks with preterm labor : Uterine contractions ≥4 in number in 20 minutes or ≥ 8 in number in 60 minutes and one of the following: * Cervical dilation ≥ 3 cm * Transvaginal cervical length \<20mm

Exclusion criteria

* Multifetal pregnancy * Cervical dilation \> 5 cm * Heavy vaginal bleeding * Non-reassuring fetal non-stress test * Preterm premature rupture of membranes * Intrauterine growth restriction * Oligohydramniosis * Fetal anomaly * Patients who received tocolytics for preterm labor or corticosteroids for lung maturation * Drug or substance use which may depress fetal breathing

Design outcomes

Primary

MeasureTime frameDescription
Expiration DurationAdmission ultrasonographyFetal Expiration Duration
Inspiration DurationAdmission ultrasonographyFetal Inspiration Duration

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026