Back to resultsFetal Thymus Volume of Dichorionic Diamniotic Twin
Primary Purpose
Twin Pregnancy, Antepartum Condition or Complication, Fetal Thymus Volume, Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
assesment of thymus volume
Sponsored by
About this trial
This is an interventional screening trial for Twin Pregnancy, Antepartum Condition or Complication
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
Sites / Locations
- Karadeniz Technical University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
dichorionic diamniotic twin pregnancy
Arm Description
rutin examination: the assesment of fetal thymus volume at all cases.
Outcomes
Primary Outcome Measures
fetal thymus volume
assesment of volume
fetal thymus volume
assesment of volume
fetal thymus volume
assesment of volume
Secondary Outcome Measures
Full Information
NCT ID
NCT04055701
First Posted
August 12, 2019
Last Updated
December 1, 2020
Sponsor
Karadeniz Technical University
1. Study Identification
Unique Protocol Identification Number
NCT04055701
Brief Title
Fetal Thymus Volume of Dichorionic Diamniotic Twin
Official Title
Relationships Between Preterm Labor and Fetal Thymus Volume in Twin Pregnancies at Second-trimester
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy, Antepartum Condition or Complication, Fetal Thymus Volume, Preterm Birth
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dichorionic diamniotic twin pregnancy
Arm Type
Other
Arm Description
rutin examination: the assesment of fetal thymus volume at all cases.
Intervention Type
Other
Intervention Name(s)
assesment of thymus volume
Intervention Description
assesment of thymus volume
Primary Outcome Measure Information:
Title
fetal thymus volume
Description
assesment of volume
Time Frame
first 6 months
Title
fetal thymus volume
Description
assesment of volume
Time Frame
last6 months
Title
fetal thymus volume
Description
assesment of volume
Time Frame
last 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Karadeniz Technical University
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26445297
Citation
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.
Results Reference
result
Learn more about this trial
Fetal Thymus Volume of Dichorionic Diamniotic Twin
We'll reach out to this number within 24 hrs