NCT03579069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 18, 2019

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

June 12, 2018

Last Update Submit

April 17, 2019

Conditions

Twin Pregnancy, MonochorionicPregnancy Followed

Keywords

Ductus venosus Doppler

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a twin to twin transfusion syndrome

    Occurrence of a twin to twin transfusion syndrome during pregnancy

    1 day

Secondary Outcomes (1)

  • neonatal mortality rate

    1 day

Study Arms (2)

Ductus venosus Doppler realized

Ductus venosus Doppler realized

Other: Ductus venosus Doppler

Ductus venosus Doppler unrealized

Ductus venosus Doppler unrealized

Interventions

Ductus venosus DopplerOTHER

Ductus venosus Doppler

Ductus venosus Doppler realized

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • Celine FOREL

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 6, 2018

Study Start

June 20, 2018

Primary Completion

July 30, 2018

Study Completion

December 31, 2018

Last Updated

April 18, 2019

Record last verified: 2018-06

Locations

FR(1)