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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655379
Other study ID # BaskentUAH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Baskent University Ankara Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date July 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Turkey Baskent University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Baskent University Ankara Hospital Batman Maternity Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Inspiration Duration Fetal Inspiration Duration Admission ultrasonography
Primary Expiration Duration Fetal Expiration Duration Admission ultrasonography
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