Twin Pregnancy, Antepartum Condition or ComplicationNCT04055701
Fetal Thymus Volume of Dichorionic Diamniotic Twin
A study testing assesment of thymus volume in people with Twin Pregnancy, Antepartum Condition or Complication and Fetal Thymus Volume, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication, Fetal Thymus Volume, Preterm Birth
- What is being tested?
- assesment of thymus volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days
Who cannot join
- Single pregnancy,
- first and third trimester pregnant women,
- urinary tract infection, immune system diseases
- fetuses with intrauterine genetic and / or multiple morphological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationships Between Preterm Labor and Fetal Thymus Volume in Twin Pregnancies at Second-trimester
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.
- Being tested
- assesment of thymus volume
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesment of thymus volumeOther
assesment of thymus volume
| Study group | Role | What they receive |
|---|---|---|
| dichorionic diamniotic twin pregnancy | Other | rutin examination: the assesment of fetal thymus volume at all cases. Receives: Other: assesment of thymus volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal thymus volume
assesment of volume
Measured: first 6 months
fetal thymus volume
assesment of volume
Measured: last6 months
fetal thymus volume
assesment of volume
Measured: last 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start15 Apr 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hidayet şal, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055701
- Sponsor's protocol ID
- Fetal Thymus and Preterm labor
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26445297
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Preterm Labor and Fetal Thymus Volume in Twin Pregnancies at Second-trimester
- ClinicalTrials.gov ID
- NCT04055701
- Acronym / sponsor ID
- Fetal Thymus and Preterm labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dichorionic diamniotic twin pregnancy | Other | Other: assesment of thymus volumerutin examination: the assesment of fetal thymus volume at all cases. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days
Key exclusion criteria (4 listed)
- Single pregnancy,
- first and third trimester pregnant women,
- urinary tract infection, immune system diseases
- fetuses with intrauterine genetic and / or multiple morphological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assesment of thymus volumeassesment of thymus volume | Other | dichorionic diamniotic twin pregnancy |
Primary outcome
fetal thymus volume
Time frame: first 6 months
assesment of volume
fetal thymus volume
Time frame: last6 months
assesment of volume
fetal thymus volume
Time frame: last 6 months
assesment of volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Results publication: PubMed 26445297Borgelt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assesment of thymus volume in people with Twin Pregnancy, Antepartum Condition or Complication and Fetal Thymus Volume, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal thymus volume (time frame: first 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.