NCT03008200

Brief Summary

Fetal PATET ratio evaluation to predict neonatal RDS

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

December 20, 2016

Last Update Submit

December 31, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome

    The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation

    Ten months

Study Arms (2)

RDS +

postpartum RDS developed group

Device: ultrasound examination

RDS -

postpartum RDS undeveloped group

Device: ultrasound examination

Interventions

intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound

RDS +RDS -

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women beyond 27 weeks

You may qualify if:

  • pregnant women within the 27 weeks of gestation and beyond

You may not qualify if:

  • patients who did not give birth within 3 days after the ultrasonographic doppler examination
  • fetuses with Any congenital abnormalities
  • amniotic fluid abnormalities
  • any chronic maternal diseases or pregnancy complications such as;gestational diabetes mellitus,preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Schenone MH, Samson JE, Jenkins L, Suhag A, Mari G. Predicting fetal lung maturity using the fetal pulmonary artery Doppler wave acceleration/ejection time ratio. Fetal Diagn Ther. 2014;36(3):208-14. doi: 10.1159/000358299. Epub 2014 Aug 13.

    PMID: 25139576BACKGROUND
  • Azpurua H, Norwitz ER, Campbell KH, Funai EF, Pettker CM, Kleine M, Bahtiyar MO, Malkus H, Copel JA, Thung SF. Acceleration/ejection time ratio in the fetal pulmonary artery predicts fetal lung maturity. Am J Obstet Gynecol. 2010 Jul;203(1):40.e1-8. doi: 10.1016/j.ajog.2010.01.075. Epub 2010 Apr 24.

    PMID: 20417479BACKGROUND
  • Guan Y, Li S, Luo G, Wang C, Norwitz ER, Fu Q, Tu X, Tian X, Zhu J. The role of doppler waveforms in the fetal main pulmonary artery in the prediction of neonatal respiratory distress syndrome. J Clin Ultrasound. 2015 Jul-Aug;43(6):375-83. doi: 10.1002/jcu.22219. Epub 2014 Aug 11.

    PMID: 25110859BACKGROUND

Study Officials

  • Barıs Buke

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pincipal Investigator

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 2, 2017

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 4, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

if necessary