Overview

This trial is active, not recruiting.

Condition twin to twin transfusion syndrome
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Société Française d’Hypentension Artérielle
Start date April 2008
End date December 2019
Trial size 179 participants
Trial identifier NCT02611856, CRC05069

Summary

The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).

These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.

For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused into the age of 5 years. This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.

The follow-up of these children should allow:

- To understand better the postnatal impact anomalies on these children in the course of pregnancy

- To anticipate and thus to improve their care in case of appearance of biological or clinical signs

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
Composite measure of the cardiac function
time frame: one day
Composite measure of the renal function
time frame: one day

Secondary Outcomes

Measure
Composite measure of the glycoregulation
time frame: one day

Eligibility Criteria

Male or female participants from 4 years up to 8 years old.

Inclusion Criteria: - Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal - Child (ren) age (s) 4 years 0 months to 6 years 12 months - Child (ren) fasting - Consent signed by the parents or legal representative Exclusion Criteria: - Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal - Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months - Child (ren) nonfasting

Additional Information

Official title STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome
Principal investigator Laurence Bussières, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.