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

NCT ID: NCT03655379

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-07-01

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

Conditions

Preterm Birth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Nasal Doppler

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

Group Type: EXPERIMENTAL

Fetal nasal Doppler by ultrasonography

Intervention Type: DEVICE

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

Interventions

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 and measurements will be performed

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Batman Maternity Hospital

UNKNOWN

Sponsor Role: collaborator

Baskent University Ankara Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sertac Esin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sertac Esin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baskent University Medical Faculty

Erhan Okuyan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Batman Kadin Dogum ve Cocuk Hastaliklari Hastanesi

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 24021995 (View on PubMed)

Other Identifiers

BaskentUAH

Identifier Type: -

Identifier Source: org_study_id