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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Device: Fetal nasal Doppler by ultrasonography

• Registration Number: NCT03655379
• Lead Sponsor: Baskent University Ankara Hospital

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

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-08-31
• Primary Completion: 2019-06-01
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-07
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal Doppler	Fetal 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

Primary Outcome Measures

Name	Time	Method
Inspiration Duration	Admission ultrasonography	Fetal Inspiration Duration
Expiration Duration	Admission ultrasonography	Fetal Expiration Duration

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Ankara, Turkey