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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fetal nasal Doppler by ultrasonography
Sponsored by
Baskent University Ankara Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Birth focused on measuring Preterm birth, Fetal nasal Doppler, Fetal breathing

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal Doppler

Arm Description

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

Outcomes

Primary Outcome Measures

Inspiration Duration
Fetal Inspiration Duration
Expiration Duration
Fetal Expiration Duration

Secondary Outcome Measures

Full Information

First Posted
August 30, 2018
Last Updated
July 7, 2019
Sponsor
Baskent University Ankara Hospital
Collaborators
Batman Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03655379
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital
Collaborators
Batman Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm birth, Fetal nasal Doppler, Fetal breathing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Doppler
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Fetal nasal Doppler by ultrasonography
Intervention Description
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
Primary Outcome Measure Information:
Title
Inspiration Duration
Description
Fetal Inspiration Duration
Time Frame
Admission ultrasonography
Title
Expiration Duration
Description
Fetal Expiration Duration
Time Frame
Admission ultrasonography

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sertac Esin, M.D.
Organizational Affiliation
Baskent University Medical Faculty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erhan Okuyan, M.D.
Organizational Affiliation
Batman Kadin Dogum ve Cocuk Hastaliklari Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06510
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24021995
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.
Results Reference
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A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns

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