Twin Pregnancy, MonochorionicDVSTTNCT03579069
Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy
An observational study of Twin Pregnancy, Monochorionic and Pregnancy Followed, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Monochorionic, Pregnancy Followed
- What is being tested?
- Ductus venosus Doppler
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to 31 Dec 2018
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre
Who may be able to join
- Monochorionic diamniotic twin pregnancies
- Monochorionicity diagnosed at the first-trimester
- Follow up and ultrasound realized at the hospital of Montpellier or Kremlin Bicêtre
- Screening for twin-twin transfusion syndrome achieved
Who cannot join
- Missing ultrasound
- Unregistered outcome of the pregnancy
- Eclampsia and pre-eclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?
Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome.
- Conditions
- Twin Pregnancy, Monochorionic, Pregnancy Followed
- Being tested
- Ductus venosus Doppler
- Keywords
- Ductus venosus Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ductus venosus DopplerOther
Ductus venosus Doppler
| Study group | Role | What they receive |
|---|---|---|
| Ductus venosus Doppler realized | Ductus venosus Doppler realized Receives: Other: Ductus venosus Doppler | |
| Ductus venosus Doppler unrealized | Ductus venosus Doppler unrealized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a twin to twin transfusion syndrome
Occurrence of a twin to twin transfusion syndrome during pregnancy
Measured: 1 day
Secondary outcomes (1)
neonatal mortality rate
neonatal mortality rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start20 Jun 2018
- Primary completion30 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, MonochorionicStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celine FOREL, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579069
- Sponsor's protocol ID
- RECHMPL18_0254
- Acronym
- DVSTT
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?
- ClinicalTrials.gov ID
- NCT03579069
- Acronym / sponsor ID
- DVSTT / RECHMPL18_0254
- Conditions
- Twin Pregnancy, Monochorionic, Pregnancy Followed
- Keywords
- Ductus venosus Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Jul 2018 (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.
Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ductus venosus Doppler realized | – | Other: Ductus venosus DopplerDuctus venosus Doppler realized |
| Ductus venosus Doppler unrealized | – | –Ductus venosus Doppler unrealized |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre
Key inclusion criteria (4 listed)
- Monochorionic diamniotic twin pregnancies
- Monochorionicity diagnosed at the first-trimester
- Follow up and ultrasound realized at the hospital of Montpellier or Kremlin Bicêtre
- Screening for twin-twin transfusion syndrome achieved
Key exclusion criteria (3 listed)
- Missing ultrasound
- Unregistered outcome of the pregnancy
- Eclampsia and pre-eclampsia
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 |
|---|---|---|
| Ductus venosus DopplerDuctus venosus Doppler | Other | Ductus venosus Doppler realized |
Primary outcome
Occurrence of a twin to twin transfusion syndrome
Time frame: 1 day
Occurrence of a twin to twin transfusion syndrome during pregnancy
1 secondary outcome
neonatal mortality rate
Time frame: 1 day
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Celine FOREL principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy, Monochorionic and Pregnancy Followed, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 3 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 18 Apr 2019. 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 France. 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?
Occurrence of a twin to twin transfusion syndrome (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.