Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

Twin to Twin Transfusion Syndrome Clinical Trial

— STT  

Official title:

STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02611856
• Other study ID #: CRC05069
• Status: Active, not recruiting
• Start date: April 3, 2007
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.

There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)

To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:

• Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),

• Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,

• Clinical examination looking for the signs of puberty

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Syndrome
• Twin to Twin Transfusion Syndrome

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Société Française d'Hypentension Artérielle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of the cardiac function	measure of the arterial blood pressure; cardiac echography	one day
Primary	Composite measure of the renal function	microalbuminuria; level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone; renal echography	one day
Secondary	Composite measure of the glycoregulation	provoked oral hyperglycemia; level of glycemia; level of insulinemia; level of glycosuria	one day