NCT04055701

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

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

April 15, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

August 12, 2019

Last Update Submit

December 1, 2020

Conditions

Twin Pregnancy, Antepartum Condition or ComplicationFetal Thymus VolumePreterm Birth

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

dichorionic diamniotic twin pregnancy

OTHER

rutin examination: the assesment of fetal thymus volume at all cases.

Other: assesment of thymus volume

Interventions

assesment of thymus volumeOTHER

assesment of thymus volume

dichorionic diamniotic twin pregnancy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 26445297RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

April 15, 2018

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

TU(1)