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

NCT03655379 | Completed

• 1 other identifier: BaskentUAH
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Birth

Keywords

Preterm birth; Fetal nasal Doppler; Fetal breathing

Outcome Measures

Primary Outcomes (2)

• Inspiration Duration

  Fetal Inspiration Duration

  Admission ultrasonography

• Expiration Duration

  Fetal Expiration Duration

  Admission ultrasonography

Study Arms (1)

Nasal Doppler

EXPERIMENTAL

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

Device: Fetal nasal Doppler by ultrasonography

Interventions

Fetal nasal Doppler by ultrasonography 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

Nasal Doppler

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead
• Batman Maternity Hospital: collaborator

Study Sites (1)

Baskent University

Ankara, 06510, Turkey (Türkiye)

Location

Related 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. Epub 2013 Sep 7.

  PMID: 24021995 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sertac Esin, M.D.

  Baskent University Medical Faculty

  PRINCIPAL INVESTIGATOR

• Erhan Okuyan, M.D.

  Batman Kadin Dogum ve Cocuk Hastaliklari Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)