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Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy (DVSTT)

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ClinicalTrials.gov Identifier: NCT03579069
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.

Condition or disease Intervention/treatment
Twin Pregnancy, Monochorionic Pregnancy Followed Other: Ductus venosus Doppler

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
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?
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : December 31, 2018


Group/Cohort Intervention/treatment
Ductus venosus Doppler realized
Ductus venosus Doppler realized
Other: Ductus venosus Doppler
Ductus venosus Doppler

Ductus venosus Doppler unrealized
Ductus venosus Doppler unrealized



Primary Outcome Measures :
  1. Occurrence of a twin to twin transfusion syndrome [ Time Frame: 1 day ]
    Occurrence of a twin to twin transfusion syndrome during pregnancy


Secondary Outcome Measures :
  1. neonatal mortality rate [ Time Frame: 1 day ]
    neonatal mortality rate



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • Missing ultrasound
  • Unregistered outcome of the pregnancy
  • Eclampsia and pre-eclampsia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579069


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Celine FOREL University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03579069     History of Changes
Other Study ID Numbers: RECHMPL18_0254
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Ductus venosus Doppler