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

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.

Study Overview

• Status: Completed
• Conditions: Twin Pregnancy, Monochorionic; Pregnancy Followed
• Intervention / Treatment: Other: Ductus venosus Doppler

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ductus venosus Doppler realized	Other: Ductus venosus Doppler; Ductus venosus Doppler
Ductus venosus Doppler unrealized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a twin to twin transfusion syndrome	Occurrence of a twin to twin transfusion syndrome during pregnancy	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal mortality rate	neonatal mortality rate	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Celine FOREL, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Ductus venosus Doppler
• Other Study ID Numbers: RECHMPL18_0254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No