Fetal Thymus Volume of Dichorionic Diamniotic Twin | NCT04055701

Studies
Fetal Thymus Volume of Dichorionic Diamniotic Twin

NCT04055701

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

Dec 2, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Twin Pregnancy, Antepartum Condition or Complication
Fetal Thymus Volume
Preterm Birth

Interventions

assesment of thymus volume

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Aug 13, 2019

First Posted Date

Aug 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2020

Last Update Posted Date

Dec 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In some studies of fetal thymus volume, fetal stress factors; infection, preterm premature premature rupture of membranes, preeclampsia, preterm delivery risk.

Generally, there is a direct correlation between fetal growth and thymus volume and it was observed that thymus volume decreased in pregnancies accompanied by fetal stress factors.The aim of this study was to measure fetal thymus volume in second trimester twin pregnancies and to investigate whether there is a statistically significant correlation between preterm birth risk pregnancies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dichorionic diamniotic twin pregnancy	Other	rutin examination: the assesment of fetal thymus volume at all cases.	Other: assesment of thymus volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assesment of thymus volume	Other	assesment of thymus volume	dichorionic diamniotic twin pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fetal thymus volume	assesment of volume	first 6 months
fetal thymus volume	assesment of volume	last6 months
fetal thymus volume	assesment of volume	last 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days

Exclusion Criteria:

Single pregnancy,
first and third trimester pregnant women,
urinary tract infection, immune system diseases
fetuses with intrauterine genetic and / or multiple morphological diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karadeniz Technical University		Trabzon		61080	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26445297	Result	Borgelt JM, Mollers M, Falkenberg MK, Amler S, Klockenbusch W, Schmitz R. Assessment of first-trimester thymus size and correlation with maternal diseases and fetal outcome. Acta Obstet Gynecol Scand. 2016 Feb;95(2):210-6. doi: 10.1111/aogs.12790. Epub 2015 Nov 17.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications