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Clinical Trials/NCT03655379
NCT03655379
Completed
Not Applicable

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

Baskent University Ankara Hospital1 site in 1 country73 target enrollmentJanuary 1, 2018
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Baskent University Ankara Hospital
Enrollment
73
Locations
1
Primary Endpoint
Inspiration Duration
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Baskent University Ankara Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sertac Esin

Associate Professor

Baskent University Ankara Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Inspiration Duration

Time Frame: Admission ultrasonography

Fetal Inspiration Duration

Expiration Duration

Time Frame: Admission ultrasonography

Fetal Expiration Duration

Study Sites (1)

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