Clinical trial NCT03655379: A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns
Official title: A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm birth
Fetal nasal Doppler
Fetal breathing
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
Collaborators: name: Batman Maternity Hospital
First posted: 2018-08-31
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Inspiration Duration
timeFrame: Admission ultrasonography
measure: Expiration Duration
timeFrame: Admission ultrasonography
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University Medical Faculty
name: Sertac Esin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Batman Kadin Dogum ve Cocuk Hastaliklari Hastanesi
name: Erhan Okuyan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boots AB, Sanchez-Ramos L, Bowers DM, Kaunitz AM, Zamora J, Schlattmann P. The short-term prediction of preterm birth: a systematic review and diagnostic metaanalysis. Am J Obstet Gynecol. 2014 Jan;210(1):54.e1-54.e10. doi: 10.1016/j.ajog.2013.09.004. Epub 2013 Sep 7.